Variable pressure cleaning device and method

ABSTRACT

Endoscopic instruments, such as endoscopes, and devices and methods for cleaning endoscopic instruments are provided. A cleaning device for use with an endoscopic instrument comprises an elongate member configured for advancement through an internal lumen within the endoscopic instrument and a cleaning member removably coupled to a portion of the elongate member. The cleaning element comprises a variable pressure region shaped and configured to increase the hydrodynamic fluid friction force and fluid pressure force of a cleaner or detergent against the wall of the internal lumen of the endoscope to more effectively clean all internal surfaces of an endoscopic instrument, including crevasses, scratches or other irregularities, without further damaging these surfaces.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/509,304, filed on Oct. 25, 2021, and entitled “Variable PressureCleaning Device and Method,” and claims benefit of U.S. ProvisionalPatent Application No. 63/105,072, filed on Oct. 23, 2020. The contentsof each of the above-identified applications is incorporated herein byreference in their entirety.

BACKGROUND

Endoscopes are used and reprocessed numerous times each day to deliverhighly advanced optical performance, consistent real-time imagingtransmission, predictable scope handling and other functionalityimportant to successful diagnosis and treatment of clinical conditions.This also occurs in non-medical applications involving the inspection,cleaning and repair of remote locations with non-medical endoscopes.This includes, by way of example, but not limitation, the inspection andrepair of hydraulic lines, oil field pipelines, oil refinery lines andlumens, sewer and plumbing lines, the internal areas of a combustionengine and other non-medical applications involving remote visualizationof an area that benefits from remote access and assessment.

Endoscopes are high technology instruments, typically having advanced,expensive optical chips at the distal end of the scope to facilitateexceptional visualization. These imaging signals are captured on thechip and communicated in turn through high definition image transfertechnology involving sophisticated software and imaging processinghardware that processes the optical signals. These signals in turn aretranslated and projected through the software and processor at numerousframes per second to an imaging screen, console or other means oftransmitting the image to a user distant from the optical chip.

The exceptional imaging capability of endoscopes has enabled numerousadvances in medical and non-medical fields. This is due in significantpart to the combination of excellent optical performance and scopehandling joined to the reusable nature of nearly all endoscopes. Thispowerful combination allows for advanced, premium optical elements to bemade available at a reasonable per use cost due to the ability to clean,disinfect (as applicable) and reuse the endoscope with its advancedoptical capability. The ability to reuse these scopes effectivelyspreads the high cost of the endoscope's capability across multipleprocedures/uses, thereby enabling reasonable, low cost access toadvanced technologies for multiple beneficial uses on a global basis.Endoscopes with these advanced optical capabilities are too expensive tobe used once and discarded. In addition, the environmental impact ofdiscarding the advanced electronics that facilitate the endoscope'scapability is considerable, unwarranted and unsafe for the environment.Reusable scopes provide a way to make peak optical capability availablefor a variety of procedures where otherwise one would not be able toafford the cost to use such technology.

Even with the considerable advances and capabilities offered by reusableendoscopes, recent concerns have arisen regarding one's ability toconsistently and predictably clean and thereby remove all soil andbiomatter that contaminates endoscopes during use. Successful cleaningis the critical step to support disinfection and/or sterilization (asapplicable) to reprocess these scopes for their next use. Cleaningnon-medical scopes is also important to avoid inhibiting scopeperformance with the next use because of retained matter that canaccumulate and adversely impact scope performance. This applies to bothnon-robotic scopes and scopes connected to or otherwise used withrobotic technology to use remote visualization to see, navigate andtreat, as applicable.

Multiple contamination-related reprocessing issues leading to potentialpatient infections and/or scope performance issues have been noted withthese scopes. These include issues with the cleanliness of reusablevalves used to facilitate suction and air/water expression, the presenceof residual matter that cannot be consistently removed from the complexdistal end of certain scopes (especially duodenoscopes and endoscopicultrasound scopes), and concerns regarding successful cleaning of thelong biopsy/working channel(s) in certain scopes that are important forpassing instruments to the distal end of the scope.

Nearly all of these issues are addressable through the use of new,relatively low cost technologies and practices that have been created inresponse to these concerns and which can be applied in the context ofcurrent workflows and procedure economics, and which are environmentallyfriendly, especially when compared to single-use scope alternatives.These relatively low cost technologies and practices include the use ofsingle-use disposable tubing and disposable valves instead of reusabletubing and valves, the use of sterile, single-use endoscopic shields toseal the complex distal end of the scope during use and initialpre-cleaning instead of leaving this area open and exposed tocontamination, the use of forced-air drying, improved adherence toreprocessing approaches, and the implementation of post-procedureculturing and monitoring to address other areas of concern.

With all of these advances, an area that remains to be addressed is thecleaning of the internal lumens of the endoscope. During a medicalprocedure, the internal biopsy and suction channels become heavilycontaminated with bacteria, biomatter and debris through the passing ofmultiple instruments through the biopsy channel and through theactuation of suction to remove mucus, debris and other matter that mayobscure the physician's visualization during the procedure. All of theseactivities benefit patients by delivering care through the scope in aless invasive manner, but in parallel with these beneficial activitiesthe scope experiences heavy contamination of these channels, which thenmust be cleaned effectively to return the scope to use for the nextpatient (or non-medical use) without exposing the next patient (ornon-medical use) to the risk of a scope-related infection (or a poorperforming, unclean non-medical scope). It is well known that withoutsuccessful cleaning, an endoscope cannot be disinfected or sterilizedsuccessfully. Unremoved biomatter and debris act as a shield forpathogens, protecting the pathogens from being killed by disinfectantsand sterilants used to reprocess the scope. Additionally, unremovedbiomatter, and pathogens create the opportunity for organisms to attachto surfaces inside the scope, engage in replication and form biofilm,which makes removal of these organisms particularly difficult and which,in turn, creates risk for the transmission of multi-drug resistantinfections through the scope. Biofilm can replicate, detach and thenattach in a new location and repeat this process, while also recruitingother organisms into the biofilm during the process, creating additionalmulti-drug resistant organisms (MDRO) that cannot be effectively treatedwith antibiotics. MDRO infections are exceptionally dangerous and haveresulted in multiple deaths around the world from contaminatedendoscopes that were not reprocessed successfully.

In the current Covid-19 pandemic, the importance of successful cleaningbecomes even more pronounced. It is now well documented that Covid-19infections begin in the lungs, but quickly migrate to thegastrointestinal tract, with virus replication occurring in these organsprior to detectable symptoms. A significant number of endoscopicprocedures involve the use of endoscopes, including by way of example,but not limitation, to examine and treat pulmonary conditions (e.g.bronchoscopies using a specialty endoscope called a bronchoscope), andto diagnose and treat conditions in the gastrointestinal tract (e.g. useof gastroscopes, duodenoscopes, endoscopic ultrasound scopes andcolonoscopes), raising the potential that Covid-19 virus could becomeencapsulated in biofilm resulting from an incomplete cleaning of anendoscope and in turn progress to a drug resistant strain of Covid-19that could be transmitted to subsequent patients. In view of all ofthese concerns, a new innovation is needed to notably improve theeffectiveness and predictability of successful cleaning of the lumens ofendoscopes.

Current Cleaning Practices and Technologies

Current endoscope channel cleaning practices utilize certain cleaningtechnologies that can increase the variability and even have apotentially adverse effect on the success of cleaning endoscopechannels. The most commonly used cleaning approach involves passing anylon wire bristle brush on the end of a long pushing/pulling elementinto the proximal end of the biopsy channel of the endoscope. The wirebrush is inserted at the biopsy port at the proximal end of the scopeand advanced down the biopsy channel to the distal end of the scope, andrepeated with other internal channels as well. This action should beperformed while the scope is submerged in a cleaning fluid with theintent being for the mechanical action of the wire bristles to removebiomatter and debris after immersing the scope in the cleaning fluid.

With this activity, after the wire bristle brush immerges at the distalend of the biopsy channel, the person performing the cleaning issupposed to examine the brush for any visible signs of debris and if anydebris is noticed, repeat this activity until no visible debris isnoticed on the brush. The goal with this series of actions is to removeall visible debris and biomatter from the internal channels in the scopethrough the mechanical action of the brush. The brushing occursfollowing immersing the scope briefly in cleaning fluid, which isintended to loosen up contaminants before passing the brush.

Limitations of Current Approaches

Current endoscopic channel cleaning approaches have a number of notablelimitations that increase the variability of cleaning results and havean overall adverse effect on the success of cleaning endoscope channels.The first issue is current cleaning approaches involve advancing acleaning brush from the proximal end of the scope at the opening of thebiopsy channel, down the channel to the distal end of the scope, whereinstruments exit the scope inside the patient. This approach means thatany biomatter, debris, bacteria and other contaminants present in thechannel are pushed from the proximal end of the scope, which is theleast complex part of the scope to clean, to the distal tip of thescope, which is the most complex part of the scope to successfully cleanand reprocess, and which is the area that has been linked to the mostscope-related infections and deaths. In essence, the cleaning brush actsas a tool that not only partially removes debris in the channel, but italso shovels or pushes contaminates out of the biopsy channel into themost difficult to clean area on the scope, with the highest level ofscope-related infection risk. Logically, one would want to do everythingpossible to do the opposite of what is currently done with the directionfor passing cleaning brushes through the biopsy channel and suctionchannel (i.e. pass from distal end to proximal end exit of the biopsychannel). This current approach with brushes occurs with certain complexscopes, such as duodenoscopes, because of limitations with currenttechnologies, including, by way of example not limitation, demonstratedissues where the complex distal end of the scope resulting in the wirebristle brush becoming stuck at the distal end and therefrom becomingnot advanceable to clean the scope's biopsy/working channel.

In addition to this limitation, the cleaning brushes themselves alsohave a number of notable limitations that inhibit consistent, repeatablescope reprocessing success. Pictures of the interior of the scope biopsychannels after cleaning with a nylon wire bristle brush reveals that thebristles deflect while being passed through the channels, leavingstreaks along the interior of the channels rather than a cleanconsistent cleaning result. These channels can be highly contaminatedwith debris, biomatter and bacteria after experiencing repeated passingof therapeutic instruments during procedures, as well as from theactuation of suction to remove debris, mucus and other biomatter duringa procedure. Using brushes that deflect and cause streaks means thatchannel cleaning is incomplete and will be highly variable. In addition,trying to offset this limitation through the use of repeated nylon wirebristle brush passes, which is recommended by the scope manufacturers,does not overcome this issue and does not result in in a predictably andcompletely clean channel. Instead, the combination of repeated passesusing a stiff bristle brush causes injury to the surface of the interiorendoscope channel, as the bristles create scratches and crevasses fromthe effects of the multiple wire passes. These scratches and crevassesallow bacteria and biomatter to infiltrate and reside in these newspaces even with multiple brush passes to clean the scope after the nextcase, limiting the consistency of the cleaning result and therebyinhibiting the ability of disinfectants and sterilants to successfullydisinfect and sterilize the scope to safely return it for use in thenext case. All biomatter and debris must be successfully removed inorder to successful disinfection and reprocess a scope. Left behindbiomatter and debris acts as a shield over pathogens that may reside inthese channels (including naturally occurring bacteria from the patient)preventing successful treatment with disinfectants and sterilants thatkill the pathogens and make the scope safe for reuse with the nextpatient.

Related to this circumstance is the assumption that personnel cleaning ascope will engage in repeated wire bristle brush passes. The scopemanufacturer's instructions for use direct the person cleaning the scopeto pass the wire bristle brush until there is no visible debris, whichis not clear evidence that brush passes have resulted in successfulcleaning, given the deflecting bristles. Additionally, it is not clearthat all persons involved in cleaning with wire bristle brushes alwaysengage in repeated brush passes (plus a visual test is not completelyaccurate). A device that can clean the biopsy channel effectively and ina single pass would be a significant way to remedy these issues.

An additional issue involves instrument injury to the biopsy channelthrough incorrect passing of instruments. The biopsy channel istypically made with PTFE or other polymeric material. It is designed toallow for predictable passing of instruments and typically has a lowcoefficient of friction to support instrument passing. The channel iscompatible with a wide range of instruments and the diameters of theinstruments passed are meaningfully smaller than the diameter of theendoscope's biopsy/working channel, providing room for safe advancementof instruments through the channel. That said, occasionally instrumentsare not used correctly, such as attempting to open a biopsy forceps inthe biopsy channel, or attempting to withdraw a biopsy forceps backthrough the channel without having the forceps properly closed. Whenthis occurs, a scratch, divot, or crevasse can result in the biopsychannel, which in turn increases the difficulty of achieving successfuland predictable removable of biomatter and debris when cleaning thebiopsy channel. There is no evidence a wire bristle brush can removedebris from injuries to the biopsy channel in a predictable andconsistent manner. Recently published data from a nationwide surveyindicates cleaning of the biopsy channels with current methods fails toremove biomatter and debris up to 15% of the time with two complexspecialty endoscopes: duodenoscopes and endoscopic ultrasound scopes.

An alternative technology to the nylon wire bristle brush is a pull thrubrush cleaner, such as the Pull Thru™ Cleaning Brush manufactured forCantel Medical. The pull thru brush cleaner is designed with fivecylindrical fins, which are arranged in very close proximity to eachother with two of the fins clustered together, followed by a largerspace and then three additional fins clustered together. The fins are aflexible polymer overmolded on to a rod of stiffer material that is usedto advance the cleaner down the scope biopsy channel from the proximalend of the scope to the distal end, while the scope is submerged incleaning fluid. The space between each cluster of fins is uniform andthe polymer between the fins is a thin, uniform thickness that isovermolded to adhere to the cylindrical monofilament. The benefit of thepull thru cleaner is less trauma to the walls of the biopsy channelcompared to a wire brush cleaner. There is also some evidence that thepull thru cleaner is able to more effectively remove biomatter from acontaminated biopsy channel.

There are, however, multiple drawbacks with pull thru cleaning brushes.Similar to the wire bristle brush, the pull thru cleaning brush isdesigned to pull debris from the proximal end of the biopsy channel tothe high-risk, difficult to clean distal end of the scope, raising thepotential contamination of the distal end as it attempts to clean thescope's biopsy channel. An additional limitation with these devices isthat the cylindrical fins are significantly oversized relative to thediameter of the biopsy channel, resulting in meaningful deflection atthe end of the fins, which creates a buckling effect that results in agap between the fin and biopsy channel. This gap or lack of consistentwall conformance can mean that not all potential contaminants areaddressed when the pull thru brush is moved through the biopsy channel.Additionally, this gap means that a change in the surface of the wall ofthe biopsy channel, such as a change due to a scratch or crevasse froman instrument pass, is unlikely to be addressed by the pull thru brushas it is moved through the biopsy channel. The fins are unable to impactscratches and crevasses as the fins pass over injuries to the channelwall.

An additional limitation that exists with all of the technologies usedto clean the internal lumens of endoscopes is the lack of acollaborative and complementary element between the two technologiesused for the cleaning steps. All reusable endoscope manufacturersrequire as a first step in the cleaning process that the endoscope beplaced in a fluid that is formulated to assist with the removable ofbiomatter and debris, followed by a second step of brushing the internalchannels while the scope is immersed in the cleaning fluid. Multipleformulations of cleaning fluid exist, but the most commonly used areeither an enzymatic cleaner, or a ph-neutral non-enzymatic cleaner. Thecleaners are intended to loosen the adhesion of biomatter and bacteriato the walls of the channel, though this is not effective on its own andeven with brushing, evidence exists that not all biomatter isconsistently removed.

One of the significant limitations of this current approach is that thecleaning fluids and brushing applications are independent technologiesthat are used together (i.e. a scope submerged in cleaning fluid whilebrushing of channels occurs), but these technologies are not designed ina way where the technologies actively complement and enhance theeffectiveness of each other. A new innovation is needed that addressesthe notable limitations of current brushing technologies and that canactively complement and work-in-concert with the cleaning fluids used inthis important cleaning step with reusable endoscopes. A new innovationis needed to address these critical limitations and assure predictableand consistent cleaning of the biopsy and suction channels and otherlumens (as applicable) of reusable endoscopes.

Accordingly, it would be desirable to provide improved systems andmethods for cleaning biomatter from endoscopic instruments, includingendoscopes, so that the instruments can be effectively sterilized ordisinfected. In particular, it would be desirable to provide devicesthat can effectively clean all internal surfaces of endoscopictechnologies, including crevasses, scratches or other irregularities,without further damaging these surfaces.

SUMMARY

Devices and methods are provided for cleaning biomatter, tissue or otherdebris from endoscopic instruments, such as endoscopes, particularlyinternal lumens or other open spaces within the endoscopic instruments.The methods and devices disclosed herein may be used with, or may beincorporated into, a variety of different reusable or disposableendoscopic instruments and devices that include internal lumens or otherinternal spaces, such as endoscopes, trocars, cannulas, dilatationdevices, Foley catheters and other in-dwelling catheters, guidewires,central venous catheters, bipolar or monopolar electrosurgical orultrasonic devices, arterial lines, drainage catheters, peripherallyinserted central catheters, endotracheal tubes, feeding tubes, and otherdevices that in-dwell, penetrate and/or navigate in the body. Thedimensions of the cleaning devices disclosed herein would, or course, beadjusted for the size of the instrument or device that is to be cleaned.

The disclosed innovations address the multiple limitations with currentapproaches for cleaning endoscope lumens or channels, and provide new,important capabilities to improve cleaning performance. In someembodiments, the devices disclosed herein overcome the notable defectswith the current channel cleaning approaches wherein brushes andcleaning fluids are not designed to work together and complement eachtechnology's respective capabilities. These innovations not only addressthe current issues with brushes, but also complement and enhance theeffectiveness of cleaning fluids used in the channels of endoscopes. Inaddition, certain embodiments provide the advantages that the lumen(s)of endoscopic instruments can be cleaned without creating defects in thesurfaces of the internal lumen. This increases the life of theinstrument and allows the instrument to be cleaned multiple timeswithout providing additional areas for biomatter, pathogens or otherdebris to reside.

In one embodiment, a cleaning device for use with an endoscopicinstrument comprises an elongate member configured for advancementthrough a lumen within the endoscopic instrument and a cleaning elementcoupled to at least a portion of the elongate member. The cleaningelement includes certain portions that have an outer diameter equal toor greater than the outer diameter of the elongate member. The cleaningelement is designed to deliver and employ one or more modalities toeffectively remove biomatter, debris and bacteria from the channels inan endoscope.

In embodiments, the elongate member comprises an attachable pushing andpulling element, such as a navigation element, that can be advanced fromthe proximal end of an internal lumen of an endoscopic instrument, suchas a biopsy channel on an endoscope, to the distal end of the biopsychannel in order to exit from the biopsy channel and connect to thecleaning element. In certain embodiments, the cleaning element isremovably attachable to a distal end portion of the navigation element.In other embodiments, the cleaning element is permanently attached tothe navigation element. These embodiments allow the cleaning element tobe translated from the distal end of the scope lumen to its proximalend, thereby avoiding the above-mentioned drawbacks with conventionalcleaning devices that transfer debris and other biomatter distallytowards the harder-to-clean areas of the scope lumens.

In one embodiment, the cleaning member comprises distal and proximal endportions having a diameter substantially equal to or greater than aninner diameter of the lumen and a variable pressure central portionbetween the distal and proximal end portions. Alternatively, theproximal and distal end portions may have a diameter substantially lessthan an inner diameter of the lumen. The variable pressure centralportion is shaped to create a pressure gradient along the centralportion from the distal end portion to the proximal end portion. Thispressure gradient causes an increase in a relative velocity between thecleaning member and fluid within the lumen as the cleaning member isadvanced through the lumen. The increased velocity of the fluidincreases the shear stress between the fluid and the lumen wall, therebycreating more force to clean the wall.

In embodiments, the proximal and distal end portions of the cleaningmember create consistent circumferential contact with the interior wallof an endoscope channel, such as a biopsy or suction channel. In certainembodiments, these channel contact elements preferably have asubstantially circumferential, cylindrical or conical shape with atleast one portion of the element having a diameter approximately equalto or slightly larger than the diameter of the internal lumen. In anexemplary embodiment, the diameter of the proximal and distal endportions is about 1 to about 1.5 times the diameter of the internallumen, preferably about 1 to about 1.25 times this diameter. This avoidsdeflection of the proximal and distal end portions, thereby reducing thebuckling and the creation of a gap between the cleaning element and theinternal wall of the lumen.

The variable pressure central portion is designed to create variablepressure between the two circumferential elements and the wall of thechannel being cleaned. Thus, as the cleaning member is advanced inside achannel and the scope and its channels are submerged in cleaning fluid(as required by scope manufacturers), the variable pressure designbetween the two circumferential elements creates a venturi effectbetween the cleaning element and the walls of the endoscope channel whenthe cleaning element is moved through the lumen. As a result, when thecleaning fluid flows across the variable pressure area, this impacts thefluid flows as it transfers from an area of high pressure across an areaof low pressure and then back to another area of high pressure betweenthe two cylindrical elements, or in embodiments, from low pressure tohigh pressure and back to low pressure. This directs the cleaning fluidat the channel walls with an increased velocity and force, therebyremoving more biomatter and other debris than conventional devices.

In certain embodiments, the central portion of the cleaning membercomprises a contraction section coupled to the proximal end portion, adiffusion section coupled to the distal end portion and a throat sectioncoupling the diffusion and contraction sections. The throat section hasa diameter less than the diameter of the proximal and distal endportions and greater than a diameter of the diffusion and contractionsections. This design enhances the performance of the cleaning fluid byturning the fluid from a static point of interaction with the walls of ascope channel, to a dynamic point of interaction where the liftingaction of the cleaning fluid's chemistry is enhanced by turning thecleaning fluid into a hydrodynamic pressure washing agent.

The variable pressure region between the two cylindrical elements mayinclude an inverted, partial venturi shape, a parabolic shape, avariable slope shape or such other shape that creates variable pressurebetween the two cylinders and the wall of the channel being cleaned,thereby increasing the force by which the cleaning fluid is projected atthe channel wall when the cleaning member is advanced. In an exemplaryembodiment, the throat section is substantially cylindrical. Thecontraction section preferably increases in diameter from the proximalend portion to the throat section and the diffusion section preferablydecreases in diameter from the throat section to the distal end portion,thereby creating a venturi effect between the distal and proximal endportions of the cleaning element.

The angle of the slope of the contraction section may vary depending onthe diameter of the channel being cleaned, the viscosity of the fluidand other factors and should be sufficient to support a variablepressure flow of cleaning fluid between the cylinders when the cleaningelement is advanced. In certain embodiments, the contraction sectiondefines an angle with the proximal end portion that is about 4 degreesto about 85 degrees, preferably between about 15 degrees to about 30degrees. Similarly, the diffusion section defines an angle with thedistal end portion that is about 4 degrees to about 85 degrees,preferably about 15 degrees to about 30 degrees. In other embodiments,the contraction section may have more than one slope, a curve shape, avariable shape or such other shape which assists in varying the pressurebetween the two cylindrical elements.

Likewise, the angle between contraction and diffusion sections and thethroat section may vary depending on the diameter of the channel beingcleaned, the viscosity of the fluid and other factors and should besufficient to support a variable pressure flow of cleaning fluid betweenthe cylinders when the cleaning element is advanced. In certainembodiments, this angle is about 10 degrees to about 50 degrees,preferably about 15 degrees to about 30 degrees and more preferablyabout 20 degrees to about 25 degrees.

The length and diameter of each section of the variable pressure regionare preferably selected to optimize the venturi effect (or inembodiments, an inverted Venturi effect) and will vary based on thediameter of the internal lumen, the viscosity of the fluid and otherfactors. For example, in a lumen having a diameter of about 4.2 mm, thelength of the throat section may be about 2 mm to 10 mm, preferablyabout 3 mm to 5 mm, and more preferably about 4 mm. The diameter of thethroat section will also depend on the diameter of the inner lumen aswell as the diameter of the contraction and diffusion sections. Incertain embodiments, the throat section has a diameter less than thediameter of the internal lumen, but greater than 50% of the diameter ofthe lumen, preferably greater than about 60% of the diameter of thelumen, and more preferably equal to or greater than about 70% of thediameter of the lumen.

When the cleaning element is advanced through a lumen having cleaningfluid therein, the variable pressure region of the cleaning element isconfigured to generate fluid pressure against the internal wall of thelumen. In certain embodiments, the variable pressure region isconfigured to generate a peak pressure of at least about 75 Pa in atleast one area between the distal and proximal end portions of thecleaning element. This peak pressure is preferably at least 100 Pa andmore preferably at least 125 Pa. In an exemplary embodiment, the peakpressure may be approximately 150 Pa. This direct pressure against thelumen wall is sufficient to remove substantially all biomatter from theinternal surface of the lumen.

The variable pressure region of the cleaning element is configured togenerate an average or mean pressure across the distance between theproximal and distal end portions of the cleaning element of at leastabout 10 Pa, preferably about 20 Pa and more preferably about 30 Pa. Inan exemplary embodiment, the mean pressure is about 36 Pa.

The variable pressure region of the cleaning element is also configuredto generate a peak shear stress of at least about 4 Pa in at least onearea between the distal and proximal end portions of the cleaningelement, preferably at least about 5 Pa and more preferably at leastabout 8 Pa. The average or mean shear stress across the distance betweenthe proximal and distal end portions of the cleaning element is at leastabout 1 Pa, preferably about 2 Pa and more preferably greater than 2.5Pa. In an exemplary embodiment the mean shear stress is about 2.8 Pa.

The variable pressure region of the cleaning element is configured togenerate a substantially high pressure across a relatively largecoverage area between the proximal and distal ends of the cleaningelement. This increases the amount of time that the inner surface of thelumen is subjected to this substantially high pressure, therebyincreasing the amount of biomatter that can be removed with the device.For definitional purposes, Applicant has defined the Peak CleaningPressure Coverage Area (PPAC™) as the distance between the proximal anddistal ends of the cleaning element in which the variable pressureregion generates a pressure above 50 Pa. In certain embodiments, thecleaning element is configured to generate a PPAC in at least about 10%of this distance, preferably at least about 25% of this distance andmore preferably at least about 40% of this distance.

The variable pressure region of the cleaning element is also configuredto generate at least some positive pressure against the internal lumenacross a relatively large coverage area between the proximal and distalends of the cleaning element. This increases the amount of time that theinner surface of the lumen is subjected to at least some cleaningpressure, thereby increasing the amount of biomatter that can be removedwith the device. For definitional purposes, Applicant has defined thePositive Pressure Cleaning Area (+PAC™) as the distance between theproximal and distal ends of the cleaning element in which the variablepressure region generates a positive pressure (i.e., above zero). Incertain embodiments, the cleaning element is configured to generate a+PAC in at least about 25% of this distance, preferably at least about50% of this distance and more preferably at least about 75% of thisdistance. In an exemplary embodiment, the +PAC may be as high as 81%.

In certain embodiments, the cleaning device/element includes more thanone cleaning member. For example, in one such embodiment, the cleaningdevice includes 2-10 cleaning members, preferably 2-5 cleaning members.The cleaning members may be coupled to each other to provide a string ofsuch cleaning members along the navigation element to increase theeffectiveness of the device. In these embodiments, for example, theproximal end portion of one cleaning member may be coupled to, or may beintegral with, the distal end portion of the next cleaning member alongthe string. Each of the cleaning members comprises distal and proximalend portions having a diameter substantially equal to or greater than aninner diameter of the lumen and a central portion between the distal andproximal end portions. The central portion of each cleaning member isshaped to create a pressure gradient along the central portion from thedistal end portion to the proximal end portion. The variable pressureelements in each cleaning member may be the same or may vary to createalternating pressure profiles. The multiple cylindrical elements withvariable pressure elements between the cylindrical elements may begreater or less than five sets, as appropriate for the givenapplication.

In one embodiment, the cleaning element is removably coupled to theelongate navigation element such that the navigation element can beadvanced from the proximal end of an endoscope lumen, such as a biopsychannel, through the lumen to its distal end. The navigation element maythen be attached to the cleaning element so that the entire system canthen be pulled from the distal end of the endoscope back through thelumen to its proximal end. Since the biopsy channel of a scope typicallycontains significant debris and biomatter, the device and methods of thecertain embodiments avoid transferring additional contamination intomore distal portions of the endoscope, which are typically the mostdifficult part of the scope to clean due to the intricate nature ofthese areas of the scope. This approach to cleaning can also be used toclean other lumens in the scope, including the suction channels and theair/water channel(s), as applicable. In other circumstances, the devicescan be used to clean from the proximal to the distal end of the channelor other endoscopic instrument to be cleaned.

In embodiments, the cleaning member, or the elongate navigation member,may include an element which centers the navigation element and thecleaning element as the device is pulled or pushed through lumens aroundturns and navigates through corners and other complex areas, includingjunctions of multiple lumens and internal channels in the scope or otherinstrument being cleaned. This centering element, in embodiments, issmaller than the diameter of the lumen through which the device is beingadvanced, but has a significant enough size to prevent misalignment anddeflection of the navigation element to one side or another of the lumenas it navigates, including as the cleaning element is pulled or pushedaround curves, corners and junctions of various lumens (including Yjunctions).

The centering element may be any shape that keeps the device generallycentered in the lumen and prevents this deflection, with a preferredembodiment being a cylindrical shape with a tapered distal end. Whenthis sort of misalignment occurs, which is an issue with existingbrushes and pull thru cleaners, the brushes and other elements arepulled to one side of the lumen as the cleaners are pulled aroundcurves, corners and junctions of lumens, with the result being contactwith the lumen wall and the cleaning element (whether a brush, pull thruor other cleaner) is minimized, altered in an adverse way, or lost,resulting in an adverse impact on the effectiveness of the cleaningapproach. By placing a centering element at the front or back, or bothof the device, this issue is corrected, resulting in more consistent,effective cleaning, especially around curves, corners, channel junctionsand other complex areas inside an endoscope or other endoscopicinstrument or device.

In a preferred embodiment, the centering element is between 50 percentand 90 percent of the diameter of the lumen being cleaned, with afurther preferred embodiment having a diameter or height between 70percent and 85 percent of the diameter of the lumen being cleaned. Thecentering element can be any shape that preserves the centering of thecleaning element as it is navigated through a channel. In embodiments,this includes cylindrical, conical, spherical and a centering elementmay be placed at the distal area of the device, at the distal andproximal end, between cleaning members, or the proximal end, asappropriate to aid in centering the cleaning element, especially as itnavigates around curves, across Y-junctions and other aspects of alumen.

In certain embodiments, the cleaning device includes a programmablemotor coupled to the elongate member and configured to translate thedevice through the lumen of the endoscopic instrument. The programmablemotor is preferably configured to withdraw the elongate member throughthe lumen a specified distance for a specified duration of time. Forexample, the motor may be programmed to withdraw the elongate member ata specific velocity that optimizes the increased velocity created by thevariable pressure region within the cleaning member, thereby ensuringthat the internal lumen is sufficiently cleaned without damaging thesurface.

In another aspect, systems and methods are provided for cleaning one ormore lumens within an endoscopic instrument. These systems and methodsare particularly designed to navigate one or more cleaning elements pastcomplex, hard-to-clean areas of an endoscope, such as junctions betweenmultiple lumens, lumens with tight internal turns, or the like.

The method comprises introducing a guidance element through a firstopening in a lumen of an instrument and advancing an elongate cleaningdevice through a second opening in the lumen such that at least aportion of the elongate cleaning device engages the guidance element.The guidance element engages and couples with the cleaning device suchthat the cleaning device can be withdrawn towards the first opening ofthe lumen with the guidance element.

In certain embodiments, the endoscope lumen comprises first and secondlumens coupled to each other at a junction, such as the Y junctionbetween the biopsy and suction channels in an endoscope. In theseembodiments, the method further comprises introducing the guidanceelement through the first lumen past the junction into the second lumenand advancing the elongate cleaning device through the second lumen suchthat the elongate cleaning device engages the guidance element. Theguidance element may then be used to withdraw the cleaning device pastthe junction and through the first lumen. This ensures that the cleaningdevice cleans the biopsy channel, rather than being deflected andcontinuing past the Y-junction proximally further into the suctionchannel.

In other embodiments, the endoscope lumen includes a turn or bend havinga relatively small radius of curvature that would otherwise be difficultto advance the cleaning element therethrough. In these embodiments, theguidance element is introduced through a lumen on one side of the turnand advanced therethrough. The cleaning device is advanced or retractedthrough the lumen on the other side of the turn until it engages withthe guidance element. The guidance element is then withdrawn to pull thecleaning device through the turn.

The guidance element may comprise a tubular sheath or similar devicehaving a distal end portion configured for engaging an end portion ofthe cleaning element. In some embodiments, the tubular sheath isremovably coupled to the cleaning element. In other embodiments, thetubular sheath may have an inner diameter larger than an outer diameterof the proximal end portion of the elongate cleaning element, and may befurther configured to deflect or otherwise direct the cleaning elementpast a junction or other tortuous area in the lumen

In certain embodiments, the tip of the guidance element is angled tofurther conform to the shape of a multi-channel internal junction in thescope. In other embodiments, the end of the navigation element may havea flange that is larger than the entry opening to the specific scopechannel where the navigation element is inserted, so that the navigationelement cannot be advanced entirely into the channel and result indifficult withdrawal. In an alternative embodiment, the navigationelement may not have a flange, but may have a marker, including forexample, a pad printed or other line, demarcating the maximumrecommended point of advancement of the navigation element into thescope channel.

In another aspect, systems and methods are provided for drying one ormore lumens within an endoscopic instrument, such as an endoscope. Thesesystems and methods are particularly useful for drying internal lumensof an endoscopic instrument after reprocessing.

In a conventional reprocessing procedure, the endoscope is disinfectedand then the channels are flushed with alcohol and either hung up to dryor dried with a forced air dryer. In a method disclosed herein, acleaning device is advanced through one or more lumens of the endoscopicinstrument. The cleaning device comprises an elongate member and atleast one cleaning member coupled to a portion of the elongate member.The cleaning member(s) comprise distal and proximal end portions and acentral portion between the distal and proximal end portions. Thecentral portion is shaped to create a pressure gradient along thecentral portion from the distal end portion to the proximal end portion.

The variable pressure central portion is shaped to create a pressuregradient along the central portion from the distal end portion to theproximal end portion. This pressure gradient causes an increase in arelative velocity between the cleaning member and air and/or alcoholwithin the lumen as the cleaning member is advanced through the lumen.The increased velocity of the fluid forces the air and/or alcohol in thechannels outward to accelerate the drying of the channels.

In other embodiments, the cleaning device may have one or more absorbentsponges placed in front of or at the end of the cleaning device or inbetween one or more of the cylindrical elements to absorb biomatter anddebris. The absorbent sponges may be of a single cell configuration orhave multiple sponges with different cell configurations to providescrubbing, absorption, lifting, diffusion of cleaning fluid, or acombination of these attributes. The absorbent sponges may comprise anymaterial that absorbs biomatter, fluid or other debris, such as apolymer, foam, sponge, bamboo, hemp, microfibers, polyurethane,polyvinyl alcohol, or the like. In one embodiment, the cleaning membercomprises a sponge-like material, such as cellulose, dry, natural and/orcompressed cellulose. In an exemplary embodiment, the material comprisesa mixture of cellulose and compressed cellulose that allows the spongeto expand when it is hydrated. Preferably, the material is selected suchthat the sponge has the ability to expand to at least the internalsurface of the lumen, while, in a preferred embodiment, maintainingsufficient absorbability to absorb a volume of material at least equalto the volume of the segment of the lumen it occupies.

In embodiments, the sponges are soft and atraumatic when immersed influid, and expand to a size that is at least sufficient to remove debrisfrom the channel being cleaned, and in a preferred embodiment is largerthan the channel being cleaned. The sponges may be any shape and sizethat conforms and aids in cleaning the scope's channel, including by wayof example, not limitation, cylindrical in shape, spiral in shape,conical, triangular, square or any combination thereof.

In embodiments, the cleaning member may have more than one cylindricalelement placed in close proximity to another, including one or moreelements, cylindrical or other shapes, with a spacing that does notcreate variable pressure on average between the elements, followed byor, alternatively, before, a cylindrical element with a spacing betweenthe next cylindrical element that creates variable pressure between thecleaning member and the wall of the channel being cleaned. Inembodiments, a series of cylindrical elements may be organized invarious spacing to create variable pressure between the cylindricalelements and certain spacing to create constant pressure between thecylindrical elements.

In other embodiments, the device may be used to clean in-dwellingdevices. In these embodiments, the device may further include a sheathor similar structure to cover the cleaning element and/or the navigationelement while translating through the lumen of the instrument to avoiddisturbing biomatter and any accumulated biofilm therein. The system mayalso include a measuring device, such as a marker on the navigationelement or a separate elongated element to confirm positioning of thedevice within the lumen of the catheter. The polymers that form thecleaning element may expand once the sheath has been withdrawn.Alternatively, electrically response polymers may be used to changeshape and enlarge with the application of energy, causing them to expandand contact the walls of the catheter, or at least in part.

In addition, the system may include a sealing element, such as acylinder or an inflatable balloon or other element, to prevent fluidfrom progressing down the catheter as the cleaning system is retractedthrough the lumen during the cleaning process. In other embodiments, thecleaning fluid or polymeric elements of the system may be capable oftransmitting electrical energy to kill bacteria prior to withdrawing thecleaning system. In yet another embodiment, the distal end of thecleaning device may include an electrical connection and an electricalpathway with an insulation covering that may be present from theproximal end of the system outside of the body to the distal end of thesystem.

The device may include a coating that is hydrophobic. In yet anotherembodiment, the device is superhydrophobic and/or oleophobic. In evenstill another embodiment, the device is anti-infective and hydrophobic.Further yet in another embodiment, the device is anti-infective andsuperhydrophobic. In further still another exemplary embodiment,anti-inflammatory coatings are incorporated into the device. In otherembodiments, the anti-inflammatory coatings may comprise a hydrophilicmaterial.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the description. Additional features of thedescription will be set forth in part in the description which followsor may be learned by practice of the description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of thedescription and together with the description, serve to explain theprinciples of the description.

FIG. 1 illustrates a representative endoscope for use with thedisinfection systems and methods disclosed herein;

FIG. 2 is a cross-sectional view of a representative endoscope, showingone or more lumens within the endoscope;

FIG. 3 illustrates damage that may occur to a representative endoscopeduring use and/or cleaning with conventional devices;

FIG. 4 is a side view of an exemplary embodiment of a cleaning element;

FIG. 5 illustrates a fluid pressure distribution created by the cleaningelement of FIG. 4 ;

FIGS. 6A and 6B illustrate direct and shear stress pressures createdagainst and along an internal lumen with the cleaning element of FIG. 4;

FIG. 7A is a side view of a cleaning device including multiple cleaningelements coupled to each other;

FIG. 7B is a side view of another embodiment of a cleaning device withmultiple cleaning elements;

FIG. 8 is a top view of a system for cleaning a lumen within anendoscopic device;

FIG. 9 is a side view of a cleaning element and a navigation element;

FIG. 10 is a side view of an alternative embodiment of a cleaningdevice;

FIGS. 11A-11D illustrate further alternative embodiments of a cleaningdevice;

FIG. 12 is a side view of another embodiment of a cleaning deviceincorporating a cleaning element and a navigation element;

FIG. 13 is a side view of a cleaning element and a navigation device,illustrating a method for removably coupling the devices together;

FIG. 14 illustrates another method for removably coupling a cleaningdevice to a navigation device;

FIG. 15 illustrates yet another method for removably coupling a cleaningdevice to a navigation device;

FIG. 16 illustrates test data from a comparison of pressures created bythe cleaning element disclosed herein and a prior art device;

FIG. 17 illustrates the peak pressure cleaning area created by thedevices of FIG. 16 ;

FIG. 18 illustrates the positive pressure cleaning areas created by thedevices of FIG. 16 ;

FIG. 19 is a perspective view of an embodiment of a cleaning deviceaccording to the alternative embodiment;

FIG. 20 illustrates use of the cleaning device of FIG. 19 within arepresentative lumen of an endoscopic instrument;

FIGS. 21A and 21B illustrate alternative embodiments of the cleaningdevice of FIG. 19 ;

FIG. 22 is a perspective view of another embodiment of a cleaningdevice;

FIG. 23 is a cross-sectional view of a distal end portion of thecleaning device of FIG. 22 ;

FIG. 24 illustrates another embodiment of a cleaning device;

FIG. 25 is a photograph of a black light inspection of a contaminatedendoscope channel;

FIGS. 26 and 27 are photographs of a black light inspection of theendoscope channel of FIG. 25 after cleaning with a prior art device;

FIG. 28 is a photograph of a black light inspection of a contaminatedendoscope channel;

FIG. 29 is a photograph of a black light inspection of the endoscopechannel of FIG. 28 after cleaning with a cleaning device disclosedherein;

FIG. 30 illustrates a guidance element for use with the cleaning devicesdisclosed herein; and

FIG. 31 illustrates another guidance element for use with the cleaningdevices disclosed herein.

DESCRIPTION OF THE EMBODIMENTS

This description and the accompanying drawings illustrate exemplaryembodiments and should not be taken as limiting, with the claimsdefining the scope of the present description, including equivalents.Various mechanical, compositional, structural, and operational changesmay be made without departing from the scope of this description and theclaims, including equivalents. In some instances, well-known structuresand techniques have not been shown or described in detail so as not toobscure the description. Like numbers in two or more figures representthe same or similar elements. Furthermore, elements and their associatedaspects that are described in detail with reference to one embodimentmay, whenever practical, be included in other embodiments in which theyare not specifically shown or described. For example, if an element isdescribed in detail with reference to one embodiment and is notdescribed with reference to a second embodiment, the element maynevertheless be claimed as included in the second embodiment. Moreover,the depictions herein are for illustrative purposes only and do notnecessarily reflect the actual shape, size, or dimensions of the systemor illustrated components.

It is noted that, as used in this specification and the appended claims,the singular forms “a,” “an,” and “the,” and any singular use of anyword, include plural referents unless expressly and unequivocallylimited to one referent. As used herein, the term “include” and itsgrammatical variants are intended to be non-limiting, such thatrecitation of items in a list is not to the exclusion of other likeitems that can be substituted or added to the listed items.

While the following description is primarily directed to an endoscopeand a device for cleaning the endoscope, it should be understood thatthe features of the presently described disinfection system may bereadily adapted for use with a variety of reusable or disposableendoscopic instruments and devices that include internal lumens or otherinternal spaces, such as endoscopes, trocars, cannulas, dilatationdevices, Foley catheters, guidewires, central venous catheters, bipolaror monopolar electrosurgical or ultrasonic devices, arterial lines,drainage catheters, peripherally inserted central catheters,endotracheal tubes, feeding tubes, and other devices that in-dwell,penetrate and/or navigate in the body.

The term “endoscope” as used herein refers generally to any scope usedon or in a medical application, which includes a body (human orotherwise) and includes, for example, a laparoscope, arthroscope,colonoscope, gastroscope, duodenoscope, endoscopic ultrasound scope,bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope,sigmoidoscope, thoracoscope, cardioscope, and saphenous vein harvesterwith a scope, whether robotic or non-robotic, or in a non-medicalapplication.

When engaged in remote visualization inside the patient's body, avariety of scopes are used. The scope used depends on the degree towhich the physician needs to navigate into the body, the type ofsurgical instruments used in the procedure and the level of invasivenessthat is appropriate for the type of procedure. For example,visualization inside the gastrointestinal tract may involve the use ofendoscopy in the form of flexible gastroscopes and colonoscopes andspecialty duodenum scopes with lengths that can run many feet anddiameters that can exceed 1 centimeter. These scopes can be turned andarticulated or steered by the physician as the scope is navigatedthrough the patient. Many of these scopes include one or more workingchannels for passing and supporting instruments, fluid channels andwashing channels for irrigating the tissue and washing the scope,insufflation channels for insufflating to improve navigation andvisualization and one or more light guides for illuminating the field ofview of the scope.

Smaller and less flexible or rigid scopes, or scopes with a combinationof flexibility and rigidity, are also used in medical applications. Forexample, a smaller, narrower and much shorter scope is used wheninspecting a joint and performing arthroscopic surgery, such as surgeryon the shoulder or knee. When a surgeon is repairing a meniscal tear inthe knee using arthroscopic surgery, a shorter, more rigid scope isusually inserted through a small incision on one side of the knee tovisualize the injury, while instruments are passed through incisions onthe opposite side of the knee. The instruments can irrigate the scopeinside the knee to maintain visualization and to manipulate the tissueto complete the repair

Other scopes may be used for diagnosis and treatment using less invasiveendoscopic procedures, including, by way of example, but not limitation,the use of scopes to inspect and treat conditions in the lung(bronchoscopes), mouth (enteroscope), urethra (cystoscope), abdomen andperitoneal cavity (laparoscope), nose and sinus (laryngoscope), anus(sigmoidoscope) and other aspects of the gastrointestinal tract(gastroscope, duodenoscope, colonoscope), chest and thoracic cavity(thoracoscope), and the heart (cardioscope). In addition, roboticmedical devices rely on scopes for remote visualization of the areas therobotic device is assessing and treating.

These and other scopes may be inserted through natural orifices (such asthe mouth, sinus, ear, urethra, anus and vagina) and through incisionsand port-based openings in the patient's skin, cavity, skull, joint, orother medically indicated points of entry. Examples of the diagnosticuse of endoscopy with visualization using these medical scopes includesinvestigating the symptoms of disease, such as maladies of the digestivesystem (for example, nausea, vomiting, abdominal pain, gastrointestinalbleeding), or confirming a diagnosis, (for example by performing abiopsy for anemia, bleeding, inflammation, and cancer) or surgicaltreatment of the disease (such as removal of a ruptured appendix orcautery of an endogastric bleed).

Referring now to FIG. 1 , a representative endoscope 10 includes aproximal handle 12 adapted for manipulation by the surgeon or cliniciancoupled to an elongate shaft 14 adapted for insertion through anendoscopic or percutaneous penetration into a body cavity of a patient.Endoscope 10 further includes a fluid delivery system 16 coupled tohandle 12 via a universal cord 15. Fluid delivery system 16 may includea number of different tubes coupled to internal lumens within shaft 14for delivery of fluid(s), such as water and air, suction, and otherfeatures that may be desired by the clinician to displace fluid, blood,debris and particulate matter from the field of view. This provides abetter view of the underlying tissue or matter for assessment andtherapy. In the representative embodiment, fluid delivery system 16includes a water-jet connector 18, water bottle connector 20, a suctionconnector 22 and an air pipe 24. Water-jet connector 18 is coupled to aninternal water-jet lumen 28 that extends through handle 12 and elongateshaft 14 to the distal end of endoscope 10. Similarly, water bottleconnector 20, suction connector and 22 air pipe 24 are each connected tointernal lumens 30, 32, 34 respectively, that pass through shaft 14 tothe distal end of endoscope 10.

Proximal handle 12 may include a variety of controls for the surgeon orclinician to operate fluid delivery system 16. In the representativeembodiment, handle 12 include a suction valve 34, and air/water valve 36and a biopsy valve 38 for extracting tissue samples from the patient.Suction channel 34 extends from suction connector 22, where it creates arelatively tight turn or bend 22A through universal cord 15 into handle12. Suction channel 34 then extends through shaft 14 to the distal endof endoscope 10. As suction channel 34 passes biopsy valve 38, itcreates an internal Y junction 38B with the channel 38C extending intobiopsy valve 38. This Y junction 38 b creates challenges for cleaningsuction channel 34 with conventional devices, as discussed in moredetail below.

Handle 12 may in certain embodiments also include an eyepiece (notshown) coupled to an image capture device (not shown), such as a lensand light transmitting system. The term “image capture device” as usedherein also need not refer to devices that only have lenses or otherlight directing structure. Instead, for example, the image capturedevice could be any device that can capture and relay an image,including (i) relay lenses between the objective lens at the distal endof the scope and an eyepiece, (ii) fiber optics, (iii) charge coupleddevices (CCD), (iv) complementary metal oxide semiconductor (CMOS)sensors. An image capture device may also be merely a chip for sensinglight and generating electrical signals for communication correspondingto the sensed light or other technology for transmitting an image. Theimage capture device may have a viewing end—where the light is captured.Generally, the image capture device can be any device that can viewobjects, capture images and/or capture video.

In some embodiments, endoscope 10 includes some form of positioningassembly (e.g., hand controls) attached to a proximal end of the shaftto allow the operator to steer the scope. In other embodiments, thescope is part of a robotic element that provides for steerability andpositioning of the scope relative to the desired point to investigateand focus the scope.

As shown in FIG. 2 , endoscope 10 may further include a camera lens 60and a light source 62 for providing a view of the surgical site in thepatient, and a biopsy channel 50 for passing instruments therethrough.The biopsy channel 50 permits passage of instruments down the shaft 14of endoscope 10 for removing tissue. Biopsy channel 50 may also functionas a working channel for other instruments to pass through endoscope 10for assessment and treatment of tissue and other matter. Suchinstruments may include cannulas, catheters, stents and stent deliverysystems, papillotomes, wires, other imaging devices includingmini-scopes, baskets, snares and other devices for use with a scope in alumen. Alternatively, endoscope 10 may include a separate workingchannel for these instruments.

FIG. 3 illustrates an internal lumen 70, such as a biopsy channel,working instrument channel or water/air channel, of a representativeendoscope. As shown, the internal surface of lumen 70 has been damagedeither during previous procedures, or by conventional cleaning devices.As such, lumen 70 includes numerous defects 72 that provide extremelysmall areas for harboring pathogens, biomatter, tissue or other debristherein. These defects 72 are very difficult to clean with conventionaldevices. Moreover, as they harbor biomatter, the biomatter protects thepathogens therein from conventional sterilization and disinfectiontechniques.

An exemplary cleaning device will now be described. The cleaning devicecomprises an elongate shaft and a cleaning member disposed on oneportion of shaft. The cleaning member may be removably attached to, orpermanently affixed to, the shaft. The shaft may comprise any suitablematerial that provides sufficient rigidity for the shaft to be advancedthrough a lumen of an endoscope. The elongate shaft has an outerdiameter sized to fit within, and translate through, the internal lumensin endoscope 10. In the exemplary embodiment, the shaft will have anouter diameter in the range of about 0.5 to about 5 mm, preferably about1 to 4 mm.

In certain embodiments, the device includes a pull cable configured towithdraw or advance elongate the shaft within an internal lumen inendoscope 10. Device may also include an energy source and a motor foradvancing and/or withdrawing the elongate shaft. Of course, it will berecognized that the elongate shaft may be manually translated throughinternal lumen via a proximal handle or suitable actuator (i.e., nomotor).

Referring now to FIG. 4 , a portion of a cleaning device 200 accordingto certain embodiments will now be described. Cleaning device 200includes one or more cleaning element(s) 300, which are attached to apushing and pulling element, such as a navigation element 301 (only aportion of which is shown in FIG. 4 ). Navigation element 301 can beadvanced from the proximal end to the distal end (or vice versa) of anyinternal lumen with the endoscope. For example, in one embodiment,navigation element 301 is advanced from the scope's biopsy channel tothe distal end of the biopsy channel in order to exit from the biopsychannel and connect to a cleaning element. Navigation element 301 mayalso be advanced from the proximal end of the scope's biopsy channel tothe distal end of the biopsy channel (or suction channel, as applicable)in order to exit from the biopsy channel and connect to a cleaningelement, or alternatively, advanced and pulled through the channel fromthe proximal end of the biopsy channel (or suction channel) to thedistal end. This pushing and/or pulling navigation element is attachableand in embodiments also detachable, and in other embodiments may bepermanently attached to cleaning element 300.

As shown in FIG. 4 , cleaning element 300 is a separate element that isconnectible to navigation element 301 such that navigation element 301can be passed through an internal lumen of an endoscopic device. Forexample, navigation element 301 can be advanced from the proximal entryto biopsy channel 38C down biopsy channel 38C, emit from the distal endof the biopsy channel and then connect to cleaning element 300 so thatthe entire system can then be pulled from the distal end of the scope upthe biopsy channel to then exit the proximal end of the biopsy channel.This approach allows the biopsy channel to be successfully cleanedwithout creating the problems with current technologies that accumulatedebris and biomatter and push this out the distal end of the biopsychannel, resulting in additional contamination at the most difficult toclean part of the scope. The unique ability to advance a navigationelement and then connect to a cleaning element at the distal end of thescope and withdraw the navigation element from the distal end to theproximal end of the scope provides for successful cleaning withoutincreasing the contamination level of the distal end of the scope, whichis the most difficult to clean part of the scope, or otherwise enter adeflection tube to pass a Y junction in a scope to enable distal toproximal cleaning with passage through a preferred side of a Y junction.This approach to cleaning can also be used to clean other lumens in thescope, including the suction channels and the air/water channel(s), asapplicable.

In other embodiments, navigation element 301 and cleaning element 300are adhered to each other and advanced or retracted through one or morelumens together. Navigation element 301 and cleaning element 300 may bemanufactured as one integral device, or they may be manufacturedseparately and attached to each other prior to use.

Channel element 300 comprises proximal and distal end portions, that arepreferably at least two channel wall contact elements 302, 304, whichare typically cylindrical in shape in order to match the shape of theendoscope's channels. Wall contact element 302, 304 create a consistentcircumferential contact with the interior wall of an endoscope channel,such as a biopsy or suction channel. In certain embodiments, channelelement may include secondary wall contact elements 303, 305 (oradditional ones if desired) to enhance the engagement between the wallcontact elements and the internal lumen walls and to ensure that thevariable pressure region (discussed below) is effective.

Channel contact elements 302, 304 may comprise any suitable shape thatsubstantially conforms to the walls of the internal lumen. In certainembodiments, channel contact elements 302, 304 preferably have asubstantially circumferential, cylindrical or conical shape with atleast one portion of the element 302, 304 having a diameterapproximately equal to or slightly larger than the diameter of theinternal lumen. In an exemplary embodiment, the largest diameter ofchannel contact elements 302, 204 is about 1 to about 1.5 times thediameter of the internal lumen, preferably about 1 to about 1.23 timesthis diameter. For example, if the diameter of the internal lumen isabout 5 mm, the largest diameter portion of elements 302, 304 may beabout 4.2 to 5.5 mm, preferably about 5 mm. This additional size allowselements 302, 304 to deform slightly as they pass through the lumen,ensuring that they will remain in contact with the lumen.

In certain embodiments, the contact elements are substantially conicalsuch that they angle downwards in the proximal direction (or thedirection of travel of the cleaning device through the lumen of theendoscope), as shown in FIG. 4 . This configuration allows contactelements 302, 304 to create a contact friction force along the internalwalls of lumen so that they can slide along the walls of internal lumenof the endoscope without getting caught or otherwise stuck in the lumen,while still ensuring that at least a portion of contact elements 302,304 remain in contact with the lumen. In an exemplary embodiment,contact elements 302, 304 are about 0.75 mm and taper to about 0.5 mm attheir tips (or the point of contact with the internal wall of thelumen).

Cleaning element 300 further includes a variable pressure region 306between wall contact elements 302, 304. Variable pressure region 306 isdesigned to create variable pressure between the two circumferentialcontact elements 302, 304 and the wall of the channel being cleaned.Thus, as the cleaning member is advanced inside a channel and the scopeand its channels are submerged in cleaning fluid (as required by scopemanufacturers, which may be saline or any other biocompatible materialsafe to use with an in-dwelling catheter), the variable pressure designbetween the two circumferential elements creates a venturi effectbetween the cleaning element and the walls of the endoscope channel whenthe cleaning element is moved through the lumen. As a result, when thecleaning fluid flows across the variable pressure area, this impacts thefluid flow as it transfers from an area of high pressure across an areaof low pressure and then back to another area of high pressure betweenthe two cylindrical elements. This directs the cleaning fluid at thechannel walls with an increased velocity and force, similar to theventuri effect created when putting one's thumb partially over the endof a garden hose to increase the force of the water emitting from thehose.

Alternatively, variable pressure region 306 may be designed to createareas of low pressure on either end of region 306 with an area of highpressure there between. In this embodiment, when the cleaning fluidflows across the variable pressure area, this impacts the fluid flow asit transfers from an area of low pressure across an area of highpressure and then back to another area of low pressure between the twocylindrical elements.

As shown in FIG. 4 , variable pressure region 306 comprises acontraction section 308 coupled to the proximal contact element 302, adiffusion section 312 coupled to the distal contact element 304 and athroat section 310 coupling the diffusion and contraction sections 308,310. The throat section 320 has a diameter less than the diameter of thecontact elements 302, 204 and greater than a diameter of the diffusionand contraction sections 308, 310. This design enhances the performanceof the cleaning fluid by turning the fluid from a static point ofinteraction with the walls of a scope channel, to a dynamic point ofinteraction where the lifting action of the cleaning fluid's chemistryis enhanced through cleaning member's direction of the fluid at thewalls of the scope channel with pressure.

Variable pressure region 306 may include an inverted, partial venturishape, a parabolic shape, a variable slope shape or such other shapethat creates variable pressure between the two cylinders and the wall ofthe channel being cleaned, thereby increasing the force by which thecleaning fluid is projected at the channel wall when the cleaning memberis advanced.

In an exemplary embodiment, throat section 310 is substantiallycylindrical. The contraction section 308 preferably increases indiameter from the contact section 302 to the throat section 310 and thediffusion section 312 preferably decreases in diameter from the throatsection 310 to contact section 304, thereby creating a venturi effectbetween the distal and proximal end portions 302, 304 of the cleaningelement 310.

In a preferred embodiment, variable pressure region 306 has an inverted,partial venturi shape with three distinct areas of various spacing fromthe wall of the scope channel, which creates accelerated hydrodynamicaction to project the cleaning fluid at the channel wall to clean moreeffectively. These areas include a contraction section 308, which is thestart of the area where cleaning fluid is present on the other side ofthe first cylindrical element. The contraction section 308 is the startof the area in which fluids accumulate and are subject to changingpressure as the space available for the fluid varies and becomes smalleras cleaning element 300 is advanced and the fluids are directed into thethroat section 310 that further alters the pressure between the cleaningelement and the channel wall. The throat section 310, wherein the shapeavailable for the fluid is reduced further in a manner that changes thepressure on the fluid compared to the pressure on the fluid in thecontraction section, creates an acceleration of the fluid as cleaningelement 300 is advanced; followed by a diffusion section 312 whichsupports the diffusion of the cleaning fluid at an accelerated speed asit exits the throat section. Collectively, these sections between thecylindrical elements create a hydrodynamic force for cleaning fluidssufficient to remove bacteria, biomatter and debris from the walls ofthe channels of the endoscope.

The angle of the slope of the contraction section 308 (defined as theangle made between the vertical section of conical section 302 and thesloped portion of contraction section 308) may vary depending on thediameter of the channel being cleaned, the viscosity of the fluid andother factors and should be sufficient to support a variable pressureflow of cleaning fluid between the cylinders when the cleaning elementis advanced. In certain embodiments, the contraction section defines anangle with the proximal end portion (i.e., contact section 302) that isabout 4 degrees to about 85 degrees, preferably between about 15 degreesto about 30 degrees. Similarly, the diffusion section defines an anglewith the distal end portion (i.e., contact section 304) that is about 4degrees to about 85 degrees, preferably about 15 degrees to about 30degrees. Of course it will be recognized that various pressure region306 may have more than one slope, a curved shape, a variable shape orsuch other shape which assists in varying the pressure between the twocylindrical elements 302, 304.

Likewise, the angle between contraction and diffusion sections 308, 312and throat section 310 may vary depending on the diameter of the channelbeing cleaned, the viscosity of the fluid and other factors, and shouldbe sufficient to support a variable pressure flow of cleaning fluidbetween the cylinders when the cleaning element is advanced. In certainembodiments, this angle is about 10 degrees to about 50 degrees,preferably about 15 degrees to about 30 degrees and more preferablyabout 20 degrees to about 25 degrees.

The length and diameter of each section of variable pressure region 306are preferably selected to optimize the venturi effect and will varybased on the diameter of the internal lumen, the viscosity of the fluidand other factors. For example, in a lumen having a diameter of about4.2 mm, the length of throat section 310 may be about 2 mm to 10 mm,preferably about 3 mm to 5 mm, and more preferably about 4 mm. The outerdiameter of throat section 310 will also depend on the diameter of theinner lumen as well as the diameter of contraction and diffusionsections 308, 312. In certain embodiments, throat section 310 is lessthan the diameter of the internal lumen, but greater than 50% of thediameter of the lumen, preferably greater than about 60% of the diameterof the lumen, and more preferably equal to or greater than about 70% ofthe diameter of the lumen (e.g., about 3 mm in a lumen having an innerdiameter of about 4.2 mm).

The outer diameter of navigation element 301 is preferably less than thediameter of throat region 310. In an exemplary embodiment, this diameteris less than about 2.5 mm, preferably less than about 2.0 mm, and morepreferably about 1.75 mm.

The venturi effect created by variable pressure region 306 impacts thefluid flows as it transfers from an area of high pressure across an areaof low pressure between the two cylindrical elements, and then back toanother area of high pressure, such that the cleaning fluid is directedat the channel walls with an increased force, similar to the venturieffect created when putting one's thumb partially over the end of agarden hose to increase the force of the water emitting from the hose.This variable pressure design means that when cleaning element 300 isattached and withdrawn or pulled with the navigation element through ascope channel, the cleaning fluid in the channel and between thecylindrical elements and the wall of the endoscope channel is movedacross the variable pressure area between the two cylindrical spheres,creating a jetting of the cleaning fluid to pressure wash the channelwalls of the endoscope channel with the cleaning fluid.

This unique capability has the powerful effect of enhancing theperformance of the cleaning fluid by turning the fluid from a staticpoint of interaction with the walls of a scope channel, to a dynamicpoint of interaction where the lifting action of the cleaning fluid'schemistry is enhanced through the cleaning element's direction of thefluid at the walls of the scope channel with pressure. Computationalmodeling using fluid dynamics shows that, in embodiments, theapplication of inverted venturi principles to create variable pressurebetween two cylindrical elements directs the cleaning fluid at all ofthe channel wall with hydrodynamic pressures of variable and increasingforce to create a new, highly effective cleaning capability that canremove debris, biomatter and bacteria from the channel, includingaddressing changes in the surface topography of the channel due to theability to direct the cleaning fluid with hydrodynamic force into anyscratches and crevasses in the scope channel.

Computational modeling and test data assessing the performance of thecleaning element indicates this innovation impacts the direction andforce of the cleaning fluid, changing the fluid from a static soakingdetergent, into an active pressure washing and cleaning modality wherethe cleaning element's variable pressure design creates a direct andbeneficial fluid force against the wall of the channel. This pressurewashing, in the form of a directed, hydrodynamic fluid force against thechannel walls, is a measurable force we call fluid friction force.

In embodiments, this variable pressure region 306 causes the cleaningfluid to be projected at the channel wall with a pressure that exceedsthe adhesion force of bacteria that may attach to the wall, creating apowerful benefit that is not present with existing brushingtechnologies. This capability enhances cleaning, just as using adetergent with a pressure washer enhances the cleaning of an externalsurface, such as using a pressure washer with detergent to removecontaminants from the side of a building or a walkway. This innovationenhances the cleaning fluid in a new and powerful way, plus adds othercapabilities in its design, changing channel cleaning performance sothat the successful cleaning of a scope channel is not dependent on theperformance of a single element, such as the unpredictable wall contactforce of a bristle brush or a pull thru cleaner, or the staticperformance of a cleaning detergent. The variable pressure region 306 ofcleaning element 300 creates hydrodynamic pressure that directs cleaningdetergent at the wall of the scope's channels. Cleaning action using thehydrodynamic pressure force to enhance cleaning fluid performance anddoing this in combination with mechanical pressure force is the best wayto achieve consistent, predictable and repeatable success with removingbiomatter and debris from the channels of endoscopes, or otherendoscopic instruments, without injury to these important channels.

The combination of cylindrical elements and a variable pressure elementis important for creating the hydrodynamic force and it adds additionalcleaning force, by making atraumatic contact with the walls of the scopechannel. These cylindrical elements add a channel wall contact pressureforce as an additional cleaning modality to remove debris and biomatterfrom the channel wall as an additional, complementary cleaningcapability that works in concert with the variable pressure elementbetween the cylinders.

When the cleaning element is advanced through a lumen having cleaningfluid therein, the variable pressure region of the cleaning element isconfigured to generate fluid pressure against the internal wall of thelumen. In certain embodiments, the variable pressure region isconfigured to generate a peak pressure of at least about 75 Pa in atleast one area between the distal and proximal end portions of thecleaning element. This peak pressure is preferably at least 100 Pa andmore preferably at least 125 Pa. In an exemplary embodiment, the peakpressure may be approximately 150 Pa. This direct pressure against thelumen wall is sufficient to remove substantially all biomatter form theinternal surface of the lumen.

The variable pressure region of the cleaning element is configured togenerate an average or mean pressure across the distance between theproximal and distal end portions of the cleaning element of at leastabout 10 Pa, preferably about 20 Pa and more preferably about 30 Pa. Inan exemplary embodiment, the mean pressure is about 36 Pa.

The variable pressure region of the cleaning element is also configuredto generate a peak shear stress of at least about 4 Pa in at least onearea between the distal and proximal end portions of the cleaningelement, preferably at least about 5 Pa and more preferably at leastabout 8 Pa. The average or mean shear stress across the distance betweenthe proximal and distal end portions of the cleaning element is at leastabout 1 Pa, preferably about 2 Pa and more preferably greater than 2.5Pa. In an exemplary embodiment the mean shear stress is about 2.8 Pa.

The variable pressure region of the cleaning element is configured togenerate a substantially high pressure across a relatively largecoverage area between the proximal and distal ends of the cleaningelement. This increases the amount of time that the inner surface of thelumen is subjected to this substantially high pressure, therebyincreasing the amount of biomatter that can be removed with the device.For definitional purposes, Applicant has defined the Peak CleaningPressure Coverage Area (PPAC™) as the distance between the proximal anddistal ends of the cleaning element in which the variable pressureregion generates a pressure above 50 Pa. In certain embodiments, thecleaning element is configured to generate a PPAC in at least about 10%of this distance, preferably at least about 25% of this distance andmore preferably at least about 40% of this distance.

The variable pressure region of the cleaning element is also configuredto generate at least some positive pressure against the internal lumenacross a relatively large coverage area between the proximal and distalends of the cleaning element. This increases the amount of time that theinner surface of the lumen is subjected to at least some cleaningpressure, thereby increasing the amount of biomatter that can be removedwith the device. For definitional purposes, Applicant has defined thePositive Pressure Cleaning Area (+PAC™) as the distance between theproximal and distal ends of the cleaning element in which the variablepressure region generates a positive pressure (i.e., above zero). Incertain embodiments, the cleaning element is configured to generate a+PAC in at least about 25% of this distance, preferably at least about50% of this distance and more preferably at least about 75% of thisdistance. In an exemplary embodiment, the +PAC may be as high as 81%.

In embodiments, a ratio of contraction may be determined between thecontraction section 308 and the throat section 310, though the ratio maychange and vary depending on the diameter of the scope channel beingcleaned, the durometer of the material used for cleaning element 300,the projected speed and force applied to withdraw the navigation element301 after it is attached to cleaning element 300 or otherwise advancedthrough the channel, the viscosity of the fluid used for cleaning, thedesired fluid friction force of the cleaning fluid projected by cleaningelement 300 and the direction of the flow exiting the throat section,including whether a narrow or broader flow is desired with the design.

The overall length of variable pressure region 306 will depend on avariety of factors, including but not limited to, the diameter of thelumen, the viscosity of the fluid within lumen, the specific shape andangles of contraction, 308, throat 310 and diffusion 312 sections andthe like. In an exemplary embodiment, the length of variable pressureregion is about 5 mm to about 20 mm, preferably about 10 mm.

Additionally, the angle of the surface of the diffusion section 312 maybe a single plane or multiple planes. In embodiments the angle of thesurface of the diffusion section 312 increases the space between thewall of the endoscope channel and cleaning element 300, in embodiments,in the diffusion section. This variation allows the fluid to accelerateat a higher pressure and velocity out of the throat section to createelevated and increasing fluid pressure force against the walls of theendoscope channel as cleaning element 300 is advanced through theendoscope channel.

In embodiments, cleaning element 300 may not have a three sectionarrangement and instead could have other shapes and forms intended tomodify the pressures between the two cylinders and create elevatedpressure sufficient to remove biomatter and debris from the walls of thescope's channels.

In embodiments, the delivery of hydrodynamic force covers a meaningfularea of the scope's channel between the two cylindrical elements, suchthat the application of the elevated force caused by cleaning element300 is not narrow and instead involves elevated force that is broaderand thereby has greater success at removing biomatter and debris. Incertain embodiments, the hydrodynamic force exceeds the attachment forceof bacteria commonly encountered in the medical procedures

FIGS. 5 and 6 illustrate the overall flow pattern of fluid flowing pastcleaning element 300 within an internal lumen of an endoscope device. Asshown in FIGS. 5 and 6A, the overall pressure distribution betweencleaning element 300 and the internal walls of the lumen creates arelatively low pressure region around contraction section 308, a higherpressure region around throat section 310 and even higher pressureregion around diffusion section 312. The hydrodynamic force is directedat a force level greater than 10 Pa across at least 50% of the distancebetween the two cylindrical elements 302, 304. In a preferredembodiment, the hydrodynamic force is directed at a level greater than10 Pa across at least 75% of the distance between the two cylindricalelements 302, 304. In an exemplary embodiment the force is greater than20 Pa across at least 50% of the distance between elements 302, 304.

FIGS. 5 and 6A also illustrate the peak pressure formed around diffusionsection 312. As shown, the peak pressure can reach as high as 100 Pa orgreater in this region. In certain embodiments, the pressure in theentire diffusion section 312 is greater than 50 Pa.

The relative fluid velocity increases from one end of cleaning element300 to another as cleaning element 300 is advanced proximally (ordistally depending on the direction of cleaning). In addition, diffusionsection 312 creates swirling fluid (not shown) in diffusion section 312that increases the pressure applied by the fluid to the internal wallsof the lumen.

FIG. 6B further illustrates the viscous shear stress created by cleaningelement 300 along the internal wall of the lumen as fluid passes betweenelement 300 and internal wall. As shown, the shear stress is greaternear cylindrical elements 302, 304. The peak shear stress is preferablygreater than about 4 Pa and more preferably greater than 7 Pa. In anexemplary embodiment, the peak shear stress reaches about 8 Pa orhigher. The average shear stress across the entire internal wall formelement 302 to element 304 is preferably greater than about 1.5 Pa, andmore preferably greater than 2.5 Pa (reaching almost 2.8 Pa in certainembodiments).

In certain embodiments, the distance between the two cylindricalelements is any distance necessary to a variable pressure shape betweenthe two cylindrical elements. In embodiments, the distance may bebetween 5 and 10 mm if the diameter of the scope channel being cleanedis between 4 mm and 4.5 mm. In other embodiments, the distance may be aratio relative to the diameter of the scope channel, such as less than4:1, less than 2:1 or less than 1.5:1 or other ratio (distance:diameterof scope channel).

The diameter of the cylindrical elements may be designed to avoiddeflection of proximal and distal end portions 302, 304. Deflection ofthese cylindrical elements can create a gap due to buckling that resultsin less than idea cleaning results. This is one of the issues with pullthru cleaners, which are as large as 5.2 mm in diameter, but are appliedin channels ranging in size from 2.8 mm to 5.0 mm in diameter and whichmust buckle to advance through the channel. In embodiments, the diameterof the cylindrical elements are between 1.0 and 1.23 times the diameterof the channel being cleaned to keep cleaning device 200 centered in thechannel being cleaned, with minimal to limited deflection of the ends ofthe cylindrical elements. Additionally, a deflection equation may beused to obtain the optimal cylindrical elements.

If the cylindrical elements are too high in diameter relative to thechannel size, this can result in ineffective cleaning due to gaps in thecylinders, deflection of the cleaning device, too much resistance topull cleaning device 200 consistently through the channel, among otherissues. The materials selected can also impact this result. Inembodiments, the material has a durometer between 35 and 70 shore A,depending on the cylinder size and design, though different durometersand multiple durometers in the same device may be used.

In embodiments, the dimensions of cleaning device 200 may allow for theadvancement of the cleaner from the distal end without being caught onthe elevator of duodenoscopes or endoscopic ultrasound scopes, which isan issue with current bristle brushes and pull through cleaners, thoughthe dimensions of the cleaning device 200 may also allow for passingthrough the scope channel in the opposite direction, from proximal todistal.

In embodiments, the cleaning device 200 may have one or more absorbentsponges placed in front of or at the end of cleaning element 300 or inbetween one or more of the cylindrical elements to absorb biomatter anddebris. The absorbent sponges may be of a single cell configuration orhave multiple sponges with different cell configurations to providescrubbing, absorption, lifting, diffusion of cleaning fluid, or acombination of these attributes. The absorbent sponges may be of anymaterial, including polyurethane, polyvinyl alcohol, or other absorbentmaterial. In embodiments, the sponges are soft and atraumatic whenimmersed in fluid, and expand to a size that is at least the size of thechannel being cleaned, and in a preferred embodiment is larger than thechannel being cleaned. The sponges may be any shape that conforms andaids in cleaning the scope's channel, including by way of example, notlimitation, cylindrical in shape, spiral in shape, conical, triangular,square or any combination thereof. In an exemplary embodiment, thesponge(s) will have a pore size of between about 200 to 1500 PPC,preferably between about 200 PPC and about 600 PPC.

The design of cleaning device 200 may vary based on the viscosity of thecleaning fluid used to clean the scope channels. In a preferredembodiment, the cleaning fluid has the viscosity of water. The design ofcleaning device 200 may also vary based on the target temperature usedto submerge the scope for cleaning. In embodiments, the target cleaningtemperature is between 25 and 35 degrees Celsius.

In embodiments, cleaning device 200 may include a brush of variousdesigns which contacts a portion of the channel wall in addition to theother aspects of cleaning element 300. The brush may be of a length thatis in the ration of 1.0 to 1.4 times the diameter of the channel to becleaned. In embodiments, the brush is preferably made of an atraumaticpolymer, such as polyurethane, with a thickness and durometer designedto limit trauma and injury to the channel wall, while maintainingsufficient rigidity to remove contamination from the walls of thechannel. The diameter of the brush elements contacting the channel wallmay be any diameter, but in embodiments may be between 0.5 and 2 mm. Thebrush elements may be perpendicular to the navigation element and inembodiments, may be part of a separate, shorter navigation elementdesigned to reach only a few a limited distance into the biopsy channel.This shorter version may be any length appropriate for cleaning theinitial entry points into the biopsy channel, but in a preferredembodiment is between 4.5 and 15 cm long. This brushing element, whetherpart of the cleaning element or in a separate shorter version, may alsoutilize nylon wire bristles or other bristles if arranged in a patternthat is effective in cleaning and minimizes trauma to the scope channel.A grip element of the brush may have a shape at one end or in the centerof the element that is larger to facilitate introduction into the biopsychannel.

In certain embodiments, cleaning device 300 may contain multiplecylindrical elements with variable pressure elements in between thecylindrical elements, such as, for example, a series of five sets ofcylindrical elements with a variable pressure element between each ofthe cylinders. The variable pressure element may be the same or may varyto create alternating pressure profiles. The multiple cylindricalelements with variable pressure elements between the cylindricalelements may be greater of less than five sets, as appropriate for thegiven application.

Referring now to FIG. 7B, one embodiment of a cleaning device 400 withmultiple cleaning elements 300 will now be described. As shown, eachcleaning element 300 includes proximal and distal end portions 302, 304and a variable pressure region 306 therebetween, as described above.Proximal and distal end portions 302, 304 are preferably cylindricalelements having an outer diameter substantially the same as the innerdiameter of the lumen to be cleaned (as discussed in detail below). Inthis embodiment, the cleaning elements are coupled to each other at theproximal and distal end portions. In an exemplary embodiment, theproximal end portion of one cleaning element is integral with the distalend portion of the next cleaning element, although it will be recognizedthat other configurations are possible. For example, cleaning device 400may have more than one cylindrical element placed in close proximity toanother cylindrical element with a spacing that does not create variablepressure, followed by or, alternatively, before, a cylindrical elementwith a spacing between the next cylindrical element that createsvariable pressure between cleaning element 300 and the wall of thechannel being cleaned. In embodiments, a series of cylindrical elementsmay be organized in various spacing to create variable pressure betweenthe cylindrical elements and certain spacing to create constant pressurebetween the cylindrical elements.

Cylindrical elements 302, 304 may be made of any shape and size thatmakes contact and conforms at least in part to the walls of the channelbeing cleaned, including in embodiments, cylindrical elements with ataper, a reverse taper, cylindrical elements that deflect and contacteach other or which deflect and do not contact another cylindricalelement, or which contact or do not contact a variable pressure shapebetween the cylindrical elements. The cylindrical elements do not haveto be cylindrical, but need to be able to assist with creating avariable pressure result with the rest of the elements of cleaningdevice 400, which means they must have wall contact that is meaningfulenough to support creating a variable pressure area to accelerate fluidflow and thereby direct the cleaning fluid at the channel wall withhydrodynamic pressure.

Cleaning device 400 may be designed to capture a certain volume ofdebris relative to the dimensions and level of contamination of thechannel being cleaned. For example, additional cylinders and variablepressure elements may be added increasing the length of cleaning device400 to capture and remove more contamination. In addition, inembodiments, a sponge or sponges of various pore size, diameter andlength may be added to increase the removal of contaminants.

In embodiments, each cleaning element 300 is between 2.5 cm and 7.5 cmlong and cleaning device 400 contains multiple variable pressure areasseparated by multiple cylindrical elements. In a preferred embodiment,cleaning device 400 contains five variable pressure areas separated bysix cylindrical elements. In certain embodiments, cleaning device 400may include two additional cylindrical elements 402, 404 at a distal endof the device 400.

Referring now to FIG. 7A, another embodiment of a cleaning device withmultiple cleaning elements will now be described. As in the previousembodiment, each cleaning element 300 includes proximal and distal endportions and a variable pressure region therebetween, as describedabove. The proximal and distal end portions are preferably cylindricalelements having an outer diameter substantially the same as the innerdiameter of the lumen to be cleaned (as discussed in detail below). Inthis embodiment, the cleaning elements are coupled to each other at theproximal and distal end portions. In an exemplary embodiment, theproximal end portion of one cleaning element is integral with the distalend portion of the next cleaning element, although it will be recognizedthat other configurations are possible.

In this embodiment, the cleaning device further includes one or moresubstantially cylindrical cleaning members 422 located at or near theproximal end of the cleaning device. Cleaning members 422 aresubstantially cylindrical and, therefore, do not include the variablepressure region discussed above.

The cleaning device may further include a centering element 424 oneither or both of the proximal and distal end portions of the cleaningdevice. Centering element(s) 424 serve to center navigation element 301and the cleaning device as the device is pulled or pushed through lumensaround turns and navigates through corners and other complex areas,including junctions of multiple lumens and internal channels in thescope or other instrument being cleaned. Centering element(s) 424, inembodiments, may be smaller than the diameter of the lumen through whichthe device is being advanced, but have a significant enough size toprevent misalignment and deflection of navigation element 301 to oneside or another of the lumen as it navigates, including as the cleaningdevice is pulled or pushed around curves, corners and junctions ofvarious lumens (including Y junctions).

Centering element(s) 424 may be any shape that keeps the devicegenerally centered and prevents this deflection, with a preferredembodiment being a cylindrical shape with a tapered distal end. Whenthis sort of misalignment occurs, which is an issue with existingbrushes and pull thru cleaners, the brushes and other elements arepulled to one side of the lumen as the cleaners are pulled aroundcurves, corners and junctions of lumens, with the result being contactwith the lumen wall and the cleaning element (whether a brush, pull thruor other cleaner) is minimized, adversely changed, or lost, resulting inan adverse impact on the effectiveness of the cleaning approach. Byplacing a centering element at the front or back, or both of the device,this issue is corrected, resulting in more consistent, effectivecleaning, especially around curves, corners, channel junctions and othercomplex areas inside an endoscope or other endoscopic instrument ordevice.

In a preferred embodiment, centering element(s) 424 are between 50percent and 90 percent of the diameter of the lumen being cleaned, witha further preferred embodiment having a diameter or height between 70percent and 85 percent of the diameter of the lumen being cleaned.Centering element(s) 424 can be any shape that preserves the centeringof the cleaning element as it is navigated through a channel. Inembodiments, this includes cylindrical, conical, spherical and acentering element may be placed at the distal area of the device, at thedistal and proximal end, between cleaning members, or the proximal end,as appropriate to aid in centering the cleaning element, especially asit navigates around curves, across Y-junctions and other aspects of alumen.

FIG. 8 illustrates a system 450 for advancing a cleaning device 400through one or more lumens of an endoscopic device. As described above,cleaning device 300 is coupled to a navigation device 301 that may, forexample, comprise an elongate wire, tube or similar component, that isflexible but has sufficient rigidness for advancement through a lumen.Navigation device 301 is coupled to a pulling element 454 that maycomprise, for example, a flexible silicone or plastic tube that hassufficient length to pass through the entire lumen of, for example, anendoscope or the like.

As shown in FIG. 9 , pulling element 454 can be molded to provide africtional resistance such that navigation device 301 can be advancedinto tube, but friction makes it difficult to withdraw device 301 frompulling element 454. In this manner, as pulling element 454 is withdrawnthrough the lumen of the endoscope, the cleaning element 300 will followpulling element 301 through the lumen.

As shown in FIGS. 30 and 31 , the system may further include a guidanceelement (750 in FIGS. 30 and 760 in FIG. 31 ) to aid in passing cleaningdevice 200 through certain difficult areas of the endoscope. Inparticular, the guidance element inhibits the navigation element fromdeflecting into the wrong channel when passing an internal junctionbetween multiple channels, such as Y junction 38B between suctionchannel 22 and biopsy channel 38C. Alternatively, the guidance devicemay be used to navigate the cleaning device through tight turns or bendsin endoscopic lumens.

In use, the guidance element 750 or 760 may be inserted into one of thescope's internal channels, such as biopsy channel 38C or suction channel22, in order to aid in passing cleaning device 200 from the distal endof scope 10 to the proximal end of biopsy channel 38C or suction channel22 to facilitate cleaning in a manner where the debris is pulled awayfrom the complex, hard-to-clean distal end of the scope in a distal toproximal motion.

Referring now to FIG. 30 , guidance element 750 comprises a hollow tube,such as a tubular sheath or the like, that may be temporarily insertedin the desired branch of an internal junction between two channels, suchthat a portion of cleaning device 200 enters into, or engages with,guidance element 750 as it is advanced through the channel and deflectsor passes into guidance element 750 to avoid advancing cleaning device200 into an unintended side of a junction or intersection of internalchannels. For example, when cleaning the biopsy channel portion 38C ofthe scope 10, if the navigation element of cleaning device 200 isadvanced from the distal to proximal end of the channel (i.e., from thedistal end of shaft 14 to biopsy valve 38), the navigation element willneed to pass internal Y junction 38B to advance up the last portion ofthe biopsy channel 38C. In certain embodiments, guidance element 750 maybe inserted from the entry point to the biopsy channel 38C past the Yjunction 38B, so that the navigation element of cleaning device 200enters into, or engages with, the guidance element and emits at the endof the biopsy channel 38C, rather than deflecting at Y junction 38B andadvancing toward suction portion of the endoscope [see, for example, thesuction valve 36 in FIG. 1 ].

In a similar manner, guidance element 750 can be inserted from thesuction valve 36 and advanced just past the internal Y junction 38B sothat passage of the navigation element of cleaning device 200 from thedistal end of the scope to the proximal end of the suction channeloccurs without a potential deflection of the navigation element at theinternal Y junction 38B.

Guidance element 750 may also be used to assist, if needed, withadvancing cleaning device 200 around a tight internal turn in theinternal channel of the endoscope, such as the exit of the channel 22 inFIG. 1 and for other assistance, if needed, with advancing thenavigation or the cleaning element.

In certain embodiments, guidance element 750 is tubular or cylindricalwith an outer diameter small than an inner diameter of the internallumen (e.g., the biopsy channel 38) and an inner lumen having a diameterthat is at least larger than the diameter of the navigation element ofcleaning device 200. In a preferred embodiment, guidance element 750 isof a shape that conforms as closely as possible to the diameter of thescope channel leading up to internal Y junction 38B or other internalareas of scope 10, with a length that reaches or extends past thejunction 38B, which, in embodiments, can be between 8 and 20 cm. As afurther preferred embodiment, with a scope with an inner channel with adiameter of 4.2 mm, the outer diameter of the guidance element would bebetween 3.5 mm and 4.15 mm and the inner diameter would be between 1.5mm and 4.05 mm.

In embodiments, guidance element 750 may comprise an angled tip tofurther conform to the shape of a multi-channel internal junction in thescope. In embodiments, the proximal end of guidance element 750 may havea flange that is larger than the entry opening to the specific scopechannel where the navigation element is inserted, so that the navigationelement cannot be advanced entirely into the channel and result indifficult withdrawal. In an alternative embodiment, guidance element 750may not have a flange, but may have a marker, including for example, apad printed or other line, demarcating the maximum recommended point ofadvancement of the navigation element into the scope channel.

FIG. 31 illustrates another embodiment of a guidance element 760 thatcomprises a substantially circular rod having an angle distal tip sothat the elongate navigation member 301 can be passed from the distalend of the scope to the suction valve opening while deflecting up intothe biopsy channel 38C at the Y junction 38B. In embodiments, theproximal end of guidance element 760 may have a flange that is largerthan the entry opening to the specific scope channel where thenavigation element is inserted, so that the navigation element cannot beadvanced entirely into the channel and result in difficult withdrawal.It may also include an angle cut at its distal end to further conform tothe shape of a multi-channel internal junction in the scope.

FIG. 10 illustrates another embodiment of a cleaning device 500 withmultiple cleaning elements 502 a, 502 b coupled to a navigation element504. As shown, cleaning elements 502 a, 502 b each include cylindricalwall contact portions 506 and a variable pressure central portion 508.In this embodiment, each central portion 508 of cleaning elements 502 a,502 b includes at least one contraction portion 510 that anglesdownwards and then a throat portion 512 that angles upwards again 512towards the luminal wall. As shown cleaning element 502 a includes anadditional portion 514 that also includes a contraction and throatportion, forming two separate variable pressure elements within a singlecleaning element 502 a. Cleaning element 502 b only includes onevariable pressure region, although it will be understood that variouscombinations of these features may be included. For example, cleaningdevice 500 may include multiple cleaning elements that each includemultiple variable pressure regions. Alternatively, each of the cleaningelements may only include one variable pressure region as shown withrespect to cleaning element 502 b. As in previous embodiments, thecombination of these sections creates variable pressure that induceshigh shear stress against the walls on the lumen.

FIGS. 11A-11D illustrates other configurations for the variable pressureregion of the cleaning element. In FIG. 11A, a cleaning element 560comprises a contraction section 562 with a larger angle between section562 and the throat 566 then the angle between throat section 566 anddiffusion section 564. FIG. 11B illustrates a cleaning element 570 thatdoes not include a specific throat section. A shown, cleaning element570 includes a contraction section 572 that immediately forms into thediffusion section 574 (i.e., angles towards the inner lumen and thenangles back inwardly without a central cylindrical throat section).

FIGS. 11C and 11D illustrate cleaning elements 550 that create multiplehigh pressure regions by comprising more than one throat section 552. Inaddition, the series of cleaning elements may each have differentconfigurations. As shown, in some instances, a cleaning element with asingle throat section can be followed by one with multiple throatsections or vice versa.

FIG. 12 illustrates yet another embodiment of a cleaning device 600 thatincludes a cleaning element 602 and a navigation element 604. In thisembodiment, navigation element 604 includes an infusion lumen 608 fordelivering air or additional fluid to cleaning element 602. Cleaningelement 602 includes one or more infusion ports 606 for delivering theair and/or fluid into the variable pressure region within the lumencreated by cleaning element 602. Delivering fluid into the variablepressure region increases the pressure therein, which thereby increasesthe fluid forces against the internal wall of the lumen to be cleaned.

Cleaning device 400 may be non-sterile or sterilized using anappropriate sterilization method, including e-beam, gamma, eto gas,hydrogen peroxide, steam or the like.

The materials for navigation element 301 can be any material sufficientto navigate through the channel being cleaned and able to manage thepull force associated with advancing cleaning element 300 through thechannel being cleaned. This includes all metal and polymer basedmaterials, including stainless steel wires, nitinol, and other metals.It also includes all polymer based materials, whether in a monofilamentform, extruded tube, braided or any other form sufficient to facilitateadvancing the cleaning element 300 though the channel being cleaned. Ina preferred embodiment, navigation element 301 is a monofilamentcomposed of nylon, polyamide, polyurethane or other polymeric material,with a diameter of at least 1 mm. Navigation element 301 may include agrip element at one end that facilitates holding and passing navigationelement 301. In embodiments, this grip element is larger than the entrypoint to the biopsy channel to protect against over advancing navigationelement 301 into the biopsy channel and losing one's grip on navigationelement 301.

In an alternative embodiment, navigation element 301 comprises one ormore internal channels that allow for cleaning fluid to be infused downnavigation element 301 to one or more ports and also allow forsuctioning fluid if desired. An infusion port may be present in cleaningdevice 300 to emit the fluid advanced through navigation element 301,allowing cleaning fluid to be infused through navigation element 302into cleaning device 200 to further modify and increase the hydrodynamicpressure of the cleaning fluid against the channel wall. In embodiments,navigation element 301 and cleaning element 302 may also contain one ormore suction channels which may be used to more rapidly circulate thecleaning fluid and/or to flush the fluid and extract debris and fluidthrough the suction channel.

In certain embodiments, navigation element 301 is attachable to thecleaning element 300 through permanent attachment, which can be throughmolding, overmolding, two shot molding, glue or other means to create anattachment between the navigation and cleaning elements where the twoelement are fixed or affixed for use. In a preferred embodiment,navigation element 301 is separately attachable and in certainembodiments attachable and detachable, so that navigation element 301may be attached from one end of a channel the other end, exit thechannel and then be attached to cleaning element 300. The means ofattachment is any way suitable for the intended use, which by way ofexample may include interlocking elements, compression fitting, a slideand locking mechanism, a loop and a hook mechanism, an insert and twistmechanism or variations and alternative combinations suitable for thediameter and shape of the navigation and cleaning elements.

FIGS. 13-15 illustrate three different embodiments for removablyattaching a shaft 400, such as a navigation element to a cleaningelement 402. As shown in FIG. 13 , cleaning element 402 may include arecess 404 for receiving a protruding section 406 of shaft 400. As shownin FIG. 15 , shaft 400 may include one or more barbs 410 that fit withinopenings 412 of cleaning element 402. Shaft 400 may include a flexiblesection 414 to allow barbs to 410 to fit within an internal lumen ofcleaning member 402. As shown in FIG. 14 , shaft 400 may include one ormore projections 420 that can be rotated into grooves on cleaning member402 to attach the cleaning member to the shaft. One skilled in the artwill appreciate that the devices and methods discloses herein are notlimited to these embodiments. For example, other methods for couplingshaft 400 to cleaning element 402 include, but are not limited toflattened monofilaments, wires, strings or filaments coupled toreleasable or non-releasable knots, crimps, press-fit elements,projections engaging with holes, channels or other openings, heatstaking, heat bending, heat piercing, hooks, snap-fit elements and thelike.

In a method according to certain embodiments, navigation element 301 isadvanced through a lumen of an endoscopic instrument, such as a biopsychannel 50 of an endoscope 10. The lumen is filled, or partially filled,with a fluid, such as an enzymatic detergent, or other cleaning fluid.The fluid functions to initially clean and/or disinfect the lumen toremove at least some of the biomatter and other pathogens from thelumen. Once the distal end portion of navigation element 302 has passedthrough the distal opening of the lumen, cleaning element 300 isremovably attached to navigation element 301 through one of the devicesand methods described above.

After attaching cleaning element 300 to navigation element 301,navigation element 301 is withdrawn back through the lumen of theinstrument. In certain embodiments, device 200 includes a pull cableconfigured to withdraw or advance elongate shaft 301 within an internallumen in endoscope 10. Device may also include an energy source and amotor for advancing and/or withdrawing navigation element 301. Ofcourse, it will be recognized that navigation element 301 may bemanually translated through internal lumen via a proximal handle orsuitable actuator (i.e., no motor).

As navigation element 301 is withdrawn through the lumen, each cleaningelement 300 creates its own variable pressure region between proximaland distal ends 302, 304. Specifically, variable pressure regions 306increase the relative velocity between the fluid within each cleaningelement 300 and the walls of cleaning element 300, which causes thefluid to accelerate relative to the internal walls of the lumen, therebycreating more fluid force against the walls (as discussed in more detailabove). This increased fluid force provides a more effective cleaningthan conventional devices.

Navigation element 301 may be withdrawn through lumen either manually orvia a motor, as described above. Preferably, navigation element 301 iswithdrawn at a predetermined speed, such as about 20-50 cm/sec,preferably about 30 cm/sec. Applicant has discovered that withdrawal atthis velocity optimizes the effects of pressure variable regions 306 onthe fluid within cleaning elements 300.

Navigation element 301 may be withdrawn only once, or it may be advancedagain, and withdrawn a second or third time, depending on the particularcleaning requirements. In certain embodiments, 301 is only withdrawpartially through the lumen before it is advanced again so that thecleaning elements do not push biomatter and other debris from theproximal portion of the scope (i.e., biopsy channel) back into thelumen.

A kit is also provided for use in cleaning an endoscopic instrument. Thekit includes any of the cleaning devices described above and may includean endoscope instrument or an endoscope, such as any of the endoscopesdescribed above in reference to FIG. 1 , or others known by thoseskilled in the art. In addition, or alternatively, the kit may include avariety of other devices used for cleaning procedures in anycombination, such as cleaning brushes, swabs and/or sponges, enzymaticcleaners, disinfectants, and other devices and agents for sterilizingand/or disinfecting medical devices, scope drying agents, test strips orother sensors for determining the effectiveness of such cleaning devices(i.e., detecting the presence of proteins, biomatter, bacteria, fungi,viruses, protein, ATP or bacteria markers, or other pathogens), personalprotective equipment (PPE), scope housings for transporting scopes toand from, for example a reprocessing location, contamination bags andthe like.

Example 1

Applicant conducted a number of tests comparing various characteristicsof the cleaning devices disclosed herein (labeled Venturi™ Cleaner inFIGS. 16-18 ) with a commercial cleaning brush, the Pull Thru™ Cleanermanufactured for Cantel Medical. The Pull Thru™ Cleaner is designed withfive cylindrical fins, which are arranged in very close proximity toeach other with two of the fins clustered together, followed by a largerspace and then three additional fins clustered together. The fins are aflexible polymer overmolded on to a rod of stiffer material that is usedto advance the cleaner down the scope biopsy channel from the proximalend of the scope to the distal end, while the scope is submerged incleaning fluid. The space between each cluster of fins is uniform andthe polymer between the fins is a thin, uniform thickness that isovermolded to adhere to the cylindrical monofilament.

FIGS. 16-18 illustrate the results of these tests. In both cases, afluid was introduced into a representative lumen of an endoscopic deviceand cleaning device 200 and the Pull Thru™ Cleaner were advanced throughthe lumen at a comparative velocities (i.e., about 30 cm/sec).Computational pressure flow modeling was conducted to measure thepositive pressure cleaning areas of both devices.

As shown in FIG. 16 , the Pull Thru™ Cleaner 700 generated a meanpressure of approximately zero (0) Pa between the proximal and distalends 702, 704 of each cleaning element 706. The cleaning device 200disclosed herein (the Venturi™ Cleaner) generated a mean pressure ofapproximately 36 Pa across the length of each cleaning element 300between cylindrical elements 302, 304. Thus, the cleaning device 200disclosed herein produced significantly greater mean pressure againstthe internal wall of the lumen than the Pull Thru™ Cleaner 700. Inaddition, the cleaning device 200 disclosed herein had peak pressuresover 50 Pa over a significant portion of cleaning element 300 (acrossthe entire throat region 312) with a maximum pressure of 150 Pa. Bycontrast, the Pull Thru™ Cleaner 700 had peak pressures over 50 Pa in avery small portion of the cleaning element 706 adjacent end 704 and amaximum pressure of only 75 Pa. Thus, the cleaning device 200 disclosedherein produced peak pressures that were dramatically higher andextended over a longer length of the device than the Pull Thru™ Cleaner700.

Referring now to FIG. 17 , the Pull Thru™ Cleaner 700 has a length ofabout 3.85 mm between proximal and distal ends 702, 704, whereascleaning device 200 disclosed herein has an average distance of about9.25 mm between cylindrical elements 302, 304. The Peak CleaningPressure Coverage Area (“PPAC™”) was considered to be the distance inwhich a cleaning fluid pressure above 50 Pa was present within eachcleaning element. The Pull Thru™ Cleaner 700 had a Peak Cleaning Area ofabout 0.58 mm or 1.5% of the total distance between ends 702, 704. Bycontrast, the cleaning device 200 disclosed herein had a Peak CleaningArea of about 3.77 mm or 41% of the total distance between cylindricalelements 302, 304.

Referring now to FIG. 18 , the Positive Pressure Cleaning Area (“+PAC™”)is defined as the distance along a cleaning element wherein the cleaningfluid pressure against the internal wall of the lumen is positive orabove zero. As shown, the Pull Thru™ Cleaner 700 had a +PAC of about0.52 mm or 13.5% of the total distance between ends 702, 704. Thecleaning device 200 disclosed herein had a +PAC of about 7.54 mm orabout 81% of the length between cylindrical elements 302, 304. Thus, thevast majority of the area between cleaning device 200 and the internalluminal wall had a positive cleaning pressure.

Example 2

Applicant also conducted a number of tests comparing the cleaningperformance of the cleaning devices disclosed herein (labeled Venturi™Endoscope Scope Cleaner in FIGS. 25-29 ) with a commercial cleaningbrush, the Pull Thru™ Cleaner manufactured for Cantel Medical. The testobjectives were to compare the cleaning performance of several differentendoscope channel cleaners in a test circumstance the follows the FDAguidance to test endoscope channel cleaning under worst-case, butclinically relevant conditions.

Fresh egg whites where combined with fluorescent dye and mixed to createa test soil. Egg whites viscosity is equivalent to the internal duodenumcontamination in a patient with various forms of disease in which bileand mucous have a higher viscosity than a normal, healthy patient. A 45cm scope biopsy channel with internal scratches made by an 0.035 hypotube to simulate instrument passage wear and tear was used for the test.Test soil in the amount of 4 mLs was infused into the test scope biopsychannel, then ends were plugged to prevent escape. The channel wasrotated and rocked back and forth to distribute the test soil evenly andthen the contaminated test channel was allowed to dry for 3 and a halfhours for a worst case scenario. Scope company guidelines requirecleaning of a contaminated channel within 1 hour of use.

After 3 and a half hours, the ends of the test channel were unplugged,the test channel was submerged in water for 10 seconds and then a TestDevice channel cleaner was advanced through the test channel

After one pass of the Test Device channel cleaner, the test channel wasinspected under black light for any residual egg white protein and dyeremaining in the channel. After each test, the Test Channel was flushed,cleaned and inspected under black light to confirm it was clean beforethe next test.

FIG. 25 illustrates a photograph of a black light inspection of acontaminated endoscope test channel 700. Egg White and Fluorescent Dyewere dried for 3 hours and 30 minutes in the channel. FIGS. 26 and 27illustrate a photograph of a black light inspection of the endoscopechannel 700 after a single pass of the Pull Thru™ Cleaner (labeled 700in FIGS. 16-18 ). The residual contamination can be seen throughout thechannel (labeled 702 in FIGS. 26 and 704 in FIG. 27 ).

FIG. 28 also illustrates a photograph of a black light inspection of acontaminated endoscope test channel 700. Egg White and Fluorescent Dyewere dried for 3 hours and 30 minutes in the channel. FIG. 29 illustratea photograph of a black light inspection of the endoscope channel 700after a single pass of the Venturi™ Endoscope Scope Cleaner. As can beseen, there is no egg white or fluorescent dye present in the channel.In addition, the channel contains no residual contamination 708.

Example 3

Cleaning the internal channels of a duodenoscope or other endoscope is acritical part of the key manual cleaning steps that must be performed aspart of reprocessing a reusable endoscope to safely and effectivelyreturn the scope to service. The FDA guidance for this portion of theoverall reprocessing process involves testing either an actual scopechannel or a representative example using a protein-based soil,preferably with blood. The preferred approach is to infuse the soil intothe channel, distribute the soil evenly and then allow the soil toremain until dry or until it reaches a worst case timeframe. Once atthis state, a channel cleaner is passed, the channel is flushed at alevel below the level normally used as part of scope reprocessing andthen the level of contamination is assessed.

A concentrated protein-based soil with added sheep's blood was preparedby Mycoscience, an independent test lab which prepared and administeredthe testing. The protein concentration was 19,421 ug/cm2, which is onthe high end of the range for duodenoscope channel contamination. A 4.2mm×180 cm PTFE duodenoscope channel was used for each test. 10 mLs ofsoil was infused into the test channel, the ends of the channel werecapped and the channel was rocked back and forth and rotated todistribute the soil evenly within the test channel. The contaminatedtest channel was allowed to sit in a container with the ends capped toprevent migration of the soil out of the test channel for two hours.This is double the one hour time limit used by endoscope manufacturersin their reprocessing testing as a worst-case approach.

After the end of the two hour period, the test channel was placed in acontainer filled with non-enzymatic cleaning detergent at aconcentration recommended for endoscope reprocessing. The endoscope testchannel was submerged in the detergent, consistent with the endoscopemanufacturer's reprocessing instructions and then the scope channelcleaner was advanced through the test channel to clean the contaminatedendoscope test channel. Consistent with the FDA's guidelines, detergentwas flushed through the endoscope test channel at a substantiallyreduced level from the amount recommended by the endoscope manufacturer.Next, the endoscope test channel was extracted with 25 mLs of extractionmedia, and residual protein counts were determined.

The test was performed comparing a Pull Thru™ Endoscope Channel Cleaner,with the Venturi™ Endoscope Channel Cleaner and with a positive controltest channel that was extracted without cleaning from a channel cleanerto confirm the level of contamination. The positive control indicatedthat the level of protein concentration for the test was 19,421 ug/cm2.The Venturi™ Cleaner reduced the level of contamination to 0.08 ug/cm2in this test. The result for the Pull Thru Cleaner was over 162 percenthigher, with the Pull Thru cleaner reducing the level of contaminationto 0.13 ug/cm2.

Referring now to FIG. 19 , a cleaning device 100 according to anotherembodiment includes an elongate shaft 102 and a cleaning member 104disposed on one portion of shaft 102. Shaft 102 may comprise anysuitable material that provides sufficient rigidity for shaft 102 to beadvanced through a lumen of an endoscope. Elongate shaft 102 has anouter diameter sized to fit within, and translate through, the internallumens in endoscope 10. In the exemplary embodiment, shaft 102 will havean outer diameter in the range of about 0.5 to about 5 mm, preferablyabout 1 to 4 mm.

In certain embodiments, device 100 includes a pull cable configured towithdraw or advance elongate shaft 102 within an internal lumen inendoscope 10. Device may also include an energy source and a motor foradvancing and/or withdrawing elongate shaft 102. Of course, it will berecognized that elongate shaft 102 may be manually translated throughinternal lumen via a proximal handle or suitable actuator (i.e., nomotor).

Cleaning member 104 preferably comprises a flexible material that isdesigned to fit within the internal lumens of an endoscope or otherendoscopic instrument and absorb or remove any debris or biomatter thatresides within the lumens. As shown, cleaning member 104 has an outerdiameter greater than the outer diameter of shaft 102 and is configuredto contact the inner surface of a lumen within the endoscope orinstrument. Cleaning member 104 comprises a material configured toabsorb tissue, biomatter or other debris from at least a portion of aninner surface of the lumen. Removing biomatter, tissue or other debriseliminates one potential area for pathogens to survive and grow withinthe instrument.

Cleaning member 104 preferably comprises a material that effectivelyabsorbs biomatter, tissue or other debris from the internal surfaces ofthe instruments without creating defects, such as scratches or the like,on these surfaces. This allows the instruments to be reused multipletimes without making them progressively more difficult to clean and/orsterilize.

As shown in FIG. 20 , cleaning member 104 preferably comprises anexpandable material that allows cleaning member 104 to expand from afirst position, wherein cleaning member 104 has an outer diameter lessthan an inner diameter of the lumen 50, to a second position whereincleaning member 104 has an outer diameter substantially equal to, orgreater than, the inner diameter of the lumen 50. In this embodiment,cleaning member 104 may be easily advanced through the lumen 50 and thenexpanded to contact the internal surfaces 52 of the lumen 50 and absorbbiomatter therefrom.

Cleaning member 104 may be expanded through a variety of different meansknown to those skilled in the art. In an exemplary embodiment, cleaningmember 104 is configured to expand upon absorption of a fluid. In thisembodiment, cleaning member 104 may be advanced into the lumen in arelatively dry state, and then allowed to absorb fluid therein, suchthat cleaning member 104 expands to a diameter equal to, or greaterthan, the inner diameter of the lumen.

Endoscopic instruments may often contain small crevasses, scratches,joints or other irregularities in the internal surfaces of the lumens(see FIG. 3 ). Cleaning member 104 is preferably configured to expandinto these crevasses and irregularities to contact the entire surfacetherein. In this manner, cleaning member 104 may absorb biomatter, fluidor tissue from within these small crevasses, thereby removingsubstantially more biomatter from the instruments than conventionalcleaning mechanisms.

Cleaning member 104 may comprise any material that absorbs biomatter,fluid or other debris, such as a polymer, foam, sponge, bamboo, hemp,microfibers, cotton or other absorbable fabric or the like. In oneembodiment, cleaning member 104 comprises a sponge-like material, suchas cellulose, dry, natural and/or compressed cellulose. In an exemplaryembodiment, the material comprises a mixture of cellulose and compressedcellulose that allows the sponge to expand when it is hydrated.Preferably, the material is selected such that the sponge has theability to expand to at least the internal surface of the lumen, whilemaintaining sufficient absorbability to absorb a volume of material atleast equal to the volume of the segment of the lumen that cleaningmember 104 occupies.

In the embodiment shown in FIG. 19 , cleaning member 104 extendsoutwardly from one segment of shaft 102 such that cleaning member 104absorbs biomatter from the internal surfaces of the lumen as shaft 102is advanced, or retracted, through the lumen. Alternatively, cleaningdevice 100 may include more than one cleaning member 104 disposed ondifferent segments of the elongate member (see FIG. 22A). In anexemplary embodiment, the cleaning member(s), alone or in combination,comprise a material configured to absorb a volume of material equal toat least the volume of the lumen.

In certain embodiments, cleaning device 100 further includes aprogrammable motor (not shown) that may be part of, or separate from,elongate shaft 102. The programmable motor is designed to withdraw shaft102 from the internal lumen of endoscope 10 at a fixed or variablevelocity. Alternatively, the motor may be programmed with a particularalgorithm that corresponds to certain cleaning objectives. In oneembodiment, the motor is programmed to withdraw elongate shaft 102 at afixed velocity based on established cleaning times required tocompletely absorb and remove biomatter from the internal lumen. In analternative embodiment, the motor is programmed to withdraw elongateshaft 102 in a series of discrete steps, i.e., holding the shaft inplace for a specified period of time and then withdrawing it a specifieddistance and repeating this step until it has been withdrawn and thecleaning procedure is complete.

In an embodiment, elongate shaft 102 is advanced or retracted through alumen of an endoscopic instrument, such as a biopsy channel 50 of anendoscope 10. The lumen may be filled, or partially filled, with afluid, such as an enzymatic detergent, or other cleaning fluid. Thefluid functions to initially clean and/or disinfect the lumen to removeat least some of the biomatter and other pathogens from the lumen. Inaddition, the fluid may be absorbed by the sponge, causing the sponge toexpand outward to the internal surface of the lumen. In preferredembodiments, the sponge will expand to a diameter greater than the innerdiameter of the lumen such that the lumen at least partially constrainsthe sponge. This ensures that the sponge will expand into any crevasses,cracks or other defects in the walls of the lumen and providessufficient pressure between the sponge and the internal walls of thelumen to allow the sponge to absorb and/or remove biomatter from thelumen as elongate shaft 102 is advanced or retracted therethrough.

In one embodiment, the method includes measuring a volume of the lumenand providing a cleaning member configured to absorb an amount ofmaterial at least equal to this volume. This ensures that cleaningmember 104 completely absorbs all fluid, biomatter, tissue or otherdebris. The volume of the lumen may be measured with a variety ofdifferent methods. In one example, one of the ends of the lumen issealed such that fluid cannot pass through that end and the opposite endis left open. Fluid is then delivered into the lumen until the lumen iscompletely full (i.e., any further delivery of fluid results in thefluid spilling out from the open end). The fluid is then emptied into asuitable measuring container to determine the volume of fluid thatoccupied the lumen.

Once the volume of a target lumen has been measured, a cleaning member104 is provided that has the capability of absorbing at least the volumeof fluid that would fill the lumen. This process can be determinedthrough a variety of different methods. In one example, the cleaningmember 104 is dried completely such that it contains substantially nofluid therein. The dried cleaning member 104 or sponge is then placedinto a container housing a large volume of fluid that has already beenmeasured. The cleaning member 104 is allowed to absorb fluid until it iscompletely saturated and the difference in fluid volume in the containerprovides the maximum absorption capability of the cleaning member.

After cleaning member 104 has been passed through the entire lumen, airis injected into the lumen to purge any remaining disinfectant solutionfrom the lumen and to dry the lumen. Alcohol, such as 70% ethyl orisopropyl alcohol, may be delivered into the lumen to promote drying.

Referring now to FIG. 21B, another embodiment will now be described. Asshown, cleaning member 108 extends outwardly from shaft 102 alongsubstantially the entire length of shaft 102, or at least the entirelength of the lumen of the endoscopic instrument. In this embodiment,cleaning member 104 has a length substantially equal to or greater thanthe length of the lumen to be cleaned. Cleaning member 104 preferablycomprises a material configured to absorb a volume of material equal toat least the internal volume of the lumen.

Cleaning device 104 may also perform the function of centering elongateshaft 102 within the internal lumen(s) of scope 10. Alternatively, or inaddition, shaft 102 may further include a centering device (not shown)at its distal end to keep cleaning device 104 optimally positionedwithin the lumen(s) such that the absorption of biomatter issubstantially uniform throughout the lumen of scope 10.

Cleaning device 100 may include one or more sensors (not shown) alongshaft 102 for detecting biomatter, pathogens, liquids or otherparticulate matter within the endoscope 10. Suitable sensors may includePCT and microarray based sensors, optical sensors (e.g., bioluminescenceand fluorescence), piezoelectric, potentiometric, amperometric,conductometric, nanosensors or the like. Shaft 102 may further includean indicator, such as a display, coupled to the sensor(s) and configuredto indicator the presence of biomatter pathogens, liquids or otherparticulars detected by the sensor. The indicator may be any suitablechemical indicator validated for cleaning and/or sterilizationprocedures that undergoes a physical or chemical change visible to thehuman eye after exposure to certain parameters. The indicator and sensormay be part of the same device, or separate from each other.

According to another aspect, some embodiments may include the ability toinfuse a disinfectant, cleaning chemical or other fluid in advance ofthe cleaning member 104 or in connection with the absorption ofbiomatter to additional germicidal effect. The fluid may also serve tolubricate the lumen so it is easier to pull elongate shaft 102 andcleaning member 104 through or for other reasons, including to leavebehind a chemistry with a longer half-life for acting as a germicide orfor other benefits.

Referring now to FIGS. 22 and 23 another embodiment will be described.As shown in FIG. 22 , a cleaning device 200 includes an elongate shaft202 and a cleaning member 204 disposed at a distal end portion of shaft202. As with the previous embodiment, shaft 202 may comprise anysuitable material that provides sufficient rigidity for shaft 202 to beadvanced through a lumen of an endoscope. Elongate shaft 202 has anouter diameter sized to fit within, and translate through, the internallumens in endoscope 10. In the exemplary embodiment, shaft 202 will havean outer diameter in the range of about 0.5 to about 5 mm, preferablyabout 1 to 4 mm.

Cleaning member 204 has an outer diameter greater than the outerdiameter of shaft 202 and is configured to contact the inner surface ofthe lumen. Cleaning member 204 comprises a material configured to removetissue, biomatter or other debris from at least a portion of an innersurface of the lumen. Removing biomatter, tissue or other debriseliminates one potential area for pathogens to survive and grow withinthe instrument.

Cleaning member 204 preferably comprises a material with a defineddegree of roughness such that it effectively removes biomatter, tissueor other debris from the internal surfaces of the instruments withoutcreating defects, such as scratches or the like, on these surfaces. Thisallows the instruments to be reused multiple times without making themprogressively more difficult to clean and/or sterilize.

Cleaning member 204 includes an outer surface 210 comprising a materialthat is smooth enough to minimize or completely avoid creating anyscratches or other defects in the surface of the lumen of the endoscopicinstrument. Conventional endoscopes and other endoscopic instrumentstypically comprise materials with high flexural strength, resistance towater and a low coefficient of friction, such as PTFE, silicone and thelike. Thus, outer surface 210 comprises a material that will minimizescratching or otherwise damaging these materials, while still havingsufficient durometer and/or roughness to clean the surfaces of thesematerials of biomatter, tissue and other debris.

In the embodiments described above, cleaning member 204 has asubstantially annular cross-sectional shape designed to conform to thecircumferential shape of an internal lumen of an endoscopic instrument.However, it will be understood that cleaning member 204 may have avariety of different shapes and configurations. For example, cleaningmember 204 may be rectangular, triangular, circular, oval, square andthe like. In addition, cleaning member 204 may include surfaceperturbations, such as projections, bristles, barbs, roughened areas, orthe like, to facilitate cleaning of the internal surface of the lumens.However, it will be understood that in embodiments any suchperturbations or bristles may be designed from a material similar to theoverall cleaning member, or with multiple different materials.

In one embodiment, cleaning member 204 has an outer diameter greaterthan the outer diameter of shaft 202 and is configured to contact theinner surface of the lumen. Cleaning member 204 may extend outwardlyfrom a distal portion of the shaft 202 such that cleaning member 204removes biomatter from the internal surfaces of the lumen as the shaft202 is advanced, or retracted, through the lumen. Alternatively, thedevice may include more than one cleaning member 204 disposed ondifferent portions of shaft 202, as shown in FIG. 24 . In otherembodiments, cleaning member 204 extends outwardly from shaft 202 alongsubstantially the entire length of shaft 202, or at least the entirelength of the lumen of the endoscopic instrument.

Hereby, all issued patents, published patent applications, andnon-patent publications that are mentioned in this specification areherein incorporated by reference in their entirety for all purposes, tothe same extent as if each individual issued patent, published patentapplication, or non-patent publication were specifically andindividually indicated to be incorporated by reference.

While several embodiments of the description have been shown in thedrawings, it is not intended that the description be limited thereto, asit is intended that the description be as broad in scope as the art willallow and that the specification be read likewise. Persons skilled inthe art will understand that the devices and methods specificallydescribed herein and illustrated in the accompanying drawings arenon-limiting exemplary embodiments. The features illustrated ordescribed in connection with one exemplary embodiment may be combinedwith the features of other embodiments. Various alternatives andmodifications can be devised by those skilled in the art withoutdeparting from the description. Accordingly, the present description isintended to embrace all such alternatives, modifications and variances.As well, one skilled in the art will appreciate further features andadvantages of the present description based on the above-describedembodiments. Accordingly, the present description is not to be limitedby what has been particularly shown and described, except as indicatedby the appended claims.

What is claimed is:
 1. A cleaning device for use with an endoscopicinstrument, the device comprising: an elongate member configured fortranslation through a lumen within the endoscopic instrument; at leastone cleaning element coupled to a portion of the elongate member,wherein the at least one cleaning element comprises distal and proximalend portions and a central portion between the distal and proximal endportions, the central portion having an outer diameter less than theproximal and distal end portions; wherein the central portion is shapedto increase a force applied by a fluid within the lumen against aninternal wall of the lumen as the cleaning element is advanced throughthe lumen, and wherein the force creates a shear stress of at leastabout 5 Pa in at least one area between the distal and proximal endportions of the cleaning element.
 2. The cleaning device of claim 1,wherein the force creates an average pressure between the proximal anddistal end portions of the cleaning element of at least about 10 Pa. 3.The cleaning device of claim 1, wherein the central portion has adistance and the force creates a pressure of at least 50 Pa in at least25% of the distance between the proximal and distal end portions of thecleaning element.
 4. The cleaning device of claim 1, wherein the centralportion has a distance and the force creates a pressure of greater than0 Pa in at least 50% of the distance between the proximal and distal endportions of the cleaning element.
 5. The cleaning device of claim 1,wherein the central portion of the cleaning element comprises acontraction section coupled to the proximal end portion, a diffusionsection coupled to the distal end portion and a throat section couplingthe diffusion and contraction sections, wherein the throat section has adiameter less than the diameter of the proximal and distal end portionsand greater than a diameter of the diffusion and contraction sections.6. The cleaning device of claim 5, wherein the contraction sectionincreases in diameter from the proximal end portion to the throatsection and the diffusion section decreases in diameter from the throatsection to the distal end portion.
 7. The cleaning device of claim 5,wherein the throat section is substantially cylindrical.
 8. The cleaningsection of claim 5, wherein the contraction section defines an anglewith the throat portion that is about 4 degrees to about 85 degrees. 9.The cleaning section of claim 5, wherein the diffusion section definesan angle with the throat portion that is about 4 degrees to about 85degrees.
 10. A cleaning device for use with an endoscopic instrument,the device comprising: an elongate member configured for translationthrough a lumen within the endoscopic instrument; at least one cleaningelement coupled to a portion of the elongate member, wherein the atleast one cleaning element comprises distal and proximal end portionsand a central portion between the distal and proximal end portions, thecentral portion having an outer diameter less than the proximal anddistal end portions; wherein the central portion is shaped to increase aforce applied by a fluid within the lumen against an internal wall ofthe lumen as the cleaning element is advanced through the lumen, andwherein the force creates an average pressure between the proximal anddistal end portions of the cleaning element of at least about 10 Pa. 11.The cleaning device of claim 10, wherein the central portion of thecleaning element comprises a contraction section coupled to the proximalend portion, a diffusion section coupled to the distal end portion and athroat section coupling the diffusion and contraction sections, whereinthe throat section has a diameter less than the diameter of the proximaland distal end portions and greater than a diameter of the diffusion andcontraction sections.
 12. The cleaning device of claim 11, wherein thecontraction section increases in diameter from the proximal end portionto the throat section and the diffusion section decreases in diameterfrom the throat section to the distal end portion.
 13. The cleaningdevice of claim 11, wherein the throat section is substantiallycylindrical.
 14. The cleaning section of claim 11, wherein thecontraction section defines an angle with the throat portion that isabout 4 degrees to about 85 degrees.
 15. The cleaning section of claim11, wherein the diffusion section defines an angle with the throatportion that is about 4 degrees to about 85 degrees.
 16. A cleaningdevice for use with an endoscopic instrument, the device comprising: anelongate member configured for translation through a lumen within theendoscopic instrument; at least one cleaning element coupled to aportion of the elongate member, wherein the at least one cleaningelement comprises distal and proximal end portions and a central portionbetween the distal and proximal end portions, the central portion havingan outer diameter less than the proximal and distal end portions;wherein the central portion is shaped to increase a force applied by afluid within the lumen against an internal wall of the lumen as thecleaning element is advanced through the lumen; and wherein the centralportion has a distance and the force creates a pressure of at least 50Pa in at least 25% of the distance between the proximal and distal endportions of the cleaning element.
 17. The cleaning device of claim 16,wherein the force creates a pressure of greater than 0 Pa in at least50% of the distance between the proximal and distal end portions of thecleaning element.
 18. The cleaning device of claim 16, wherein thecentral portion of the cleaning element comprises a contraction sectioncoupled to the proximal end portion, a diffusion section coupled to thedistal end portion and a throat section coupling the diffusion andcontraction sections, wherein the throat section has a diameter lessthan the diameter of the proximal and distal end portions and greaterthan a diameter of the diffusion and contraction sections.
 19. Thecleaning device of claim 18, wherein the contraction section increasesin diameter from the proximal end portion to the throat section and thediffusion section decreases in diameter from the throat section to thedistal end portion.
 20. The cleaning device of claim 18, wherein thethroat section is substantially cylindrical.
 21. The cleaning section ofclaim 18, wherein the contraction section defines an angle with thethroat portion that is about 4 degrees to about 85 degrees.
 22. Thecleaning section of claim 18, wherein the diffusion section defines anangle with the throat portion that is about 4 degrees to about 85degrees.